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NAD Precursors Billing & Prior-Auth Playbook

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At a glance

  • What is sold / Oral NMN and NR as supplements; injectable NAD+ as a compounded product [1][2]
  • Approval status / No NAD+-precursor product is approved to treat aging or any disease [1]
  • NMN today / Lawful in dietary supplements after FDA's September 2025 reversal; new-dietary-ingredient rules still apply [1]
  • NR / Sold as a supplement; FDA had no questions on one company's GRAS notice in 2016 and made no GRAS finding of its own [3]
  • Human data / Blood NAD+ rises with oral NMN and NR in randomized trials; clinical benefit is uncertain [4][5][6]

Is there an approved drug to bill?

No. No NAD+-precursor product is approved by FDA to treat aging or any disease [1], and injectable or IV NAD+ is a compounded product, not an approved drug [2]. There is no approved label or labeled indication in this class.

Where each product stands

NMN

Trade press reported that in 2022 FDA told two ingredient makers that NMN was excluded from the supplement definition under the drug-exclusion clause. The Natural Products Association and the Alliance for Natural Health USA filed a citizen petition in March 2023 (docket FDA-2023-P-0872), and FDA sent an interim no-decision response on 30 August 2023 [7]. On 29 September 2025 FDA posted a partial approval and denial response concluding that NMN is not excluded, because it found evidence NMN was sold as a supplement in the US before it was authorized for drug investigation [1]. Before selling NMN, a maker must file a new-dietary-ingredient notification or rely on a prior notification covering its ingredient [1]. NMN is still not an FDA-approved drug [1].

NR

FDA answered ChromaDex's GRAS notice GRN 000635 with a no-questions letter dated 3 August 2016 and stated that it had not made its own GRAS determination [3]. NR is sold as a dietary supplement [1].

Injectable NAD+

Injectable or IV NAD+ is a compounded product and is not an FDA-approved drug [2].

What human trials have found

Blood NAD+ rises with oral NMN and NR in randomized trials: NMN 250 mg/day for 12 weeks in 30 healthy adults [4], NMN 300 to 900 mg/day for 60 days in 80 middle-aged adults [5], and a six-week randomized crossover trial in which NR increased NAD+ metabolism in middle-aged and older adults [6]. One 10-week trial in postmenopausal women with prediabetes found NMN improved insulin-stimulated glucose disposal [8]. Broader clinical benefit remains uncertain: in a 21-day trial of 12 older men, NR did not raise muscle NAD+ although a marker of NAD+ synthesis doubled, and mitochondrial respiration was unchanged [9]; a 2025 meta-analysis found NMN had no significant effect on skeletal muscle index, handgrip strength, gait speed or the chair-stand test in older adults [10]; and a 2025 meta-analysis of 12 studies and 513 participants found most metabolic outcomes did not differ from control [11].

Frequently asked questions

Will insurance pay for an IV NAD+ infusion?
FDA's status information does not establish coverage. Injectable NAD+ is compounded and is not an FDA-approved drug [2].
Is NMN still excluded from the supplement definition?
No. FDA responded to the citizen petition on 29 September 2025 and concluded NMN is not excluded [1]. Before selling it, a maker must file a new-dietary-ingredient notification or rely on a prior notification covering its ingredient [1].
What doses were used in the human trials?
NMN: 250 mg/day for 12 weeks [4], 300 to 900 mg/day for 60 days [5], and 1,250 mg once daily for up to 4 weeks [12]. NR: 2,000 mg/day for 12 weeks [13] and 3,000 mg/day for 4 weeks in Parkinson disease [14]. These are studied doses, not recommended doses.

References

  1. Official web page. Official web page
  2. Bulk Drug Substances Used in Compounding of the FD&C Act | FDA. Bulk Drug Substances Used in Compounding of the FD&C Act | FDA
  3. Agency Response Letter GRAS Notice No. GRN 000635 | FDA. Agency Response Letter GRAS Notice No. GRN 000635 | FDA
  4. Okabe K, Yaku K, Uchida Y, Fukamizu Y, Sato T, Sakurai T, et al. Oral Administration of Nicotinamide Mononucleotide Is Safe and Efficiently Increases Blood Nicotinamide Adenine Dinucleotide Levels in Healthy Subjects. Front Nutr. 2022;9:868640. Oral Administration of Nicotinamide Mononucleotide Is Safe and Efficiently Increases Blood Nicotinamide Adenine Dinucleotide Levels in Healthy Subjects
  5. Yi L, Maier AB, Tao R, Lin Z, Vaidya A, Pendse S, et al. The efficacy and safety of β-nicotinamide mononucleotide (NMN) supplementation in healthy middle-aged adults: a randomized, multicenter, double-blind, placebo-controlled, parallel-group, dose-dependent clinical trial. Geroscience. 2023;45(1):29-43. The efficacy and safety of β-nicotinamide mononucleotide (NMN) supplementation in healthy middle-aged adults: a randomized, multicenter, double-blind, placebo-controlled, parallel-group, dose-dependent clinical trial
  6. Martens CR, Denman BA, Mazzo MR, Armstrong ML, Reisdorph N, McQueen MB, et al. Chronic nicotinamide riboside supplementation is well-tolerated and elevates NAD+ in healthy middle-aged and older adults. Nat Commun. 2018;9(1):1286. Chronic nicotinamide riboside supplementation is well-tolerated and elevates NAD+ in healthy middle-aged and older adults
  7. Official web page. Official web page
  8. Yoshino M, Yoshino J, Kayser BD, Patti GJ, Franczyk MP, Mills KF, et al. Nicotinamide mononucleotide increases muscle insulin sensitivity in prediabetic women. Science. 2021;372(6547):1224-1229. Nicotinamide mononucleotide increases muscle insulin sensitivity in prediabetic women
  9. Elhassan YS, Kluckova K, Fletcher RS, Schmidt MS, Garten A, Doig CL, et al. Nicotinamide Riboside Augments the Aged Human Skeletal Muscle NAD+ Metabolome and Induces Transcriptomic and Anti-inflammatory Signatures. Cell Rep. 2019;28(7):1717-1728.e6. Nicotinamide Riboside Augments the Aged Human Skeletal Muscle NAD+ Metabolome and Induces Transcriptomic and Anti-inflammatory Signatures
  10. Prokopidis K, Moriarty F, Bahat G, McLean J, Church DD, Patel HP. The Effect of Nicotinamide Mononucleotide and Riboside on Skeletal Muscle Mass and Function: A Systematic Review and Meta-Analysis. J Cachexia Sarcopenia Muscle. 2025;16(3):e13799. The Effect of Nicotinamide Mononucleotide and Riboside on Skeletal Muscle Mass and Function: A Systematic Review and Meta-Analysis
  11. Zhang J, Poon ET, Wong SH. Efficacy of oral nicotinamide mononucleotide supplementation on glucose and lipid metabolism for adults: a systematic review with meta-analysis on randomized controlled trials. Crit Rev Food Sci Nutr. 2025;65(22):4382-4400. Efficacy of oral nicotinamide mononucleotide supplementation on glucose and lipid metabolism for adults: a systematic review with meta-analysis on randomized controlled trials
  12. Fukamizu Y, Uchida Y, Shigekawa A, Sato T, Kosaka H, Sakurai T. Safety evaluation of β-nicotinamide mononucleotide oral administration in healthy adult men and women. Sci Rep. 2022;12(1):14442. Safety evaluation of β-nicotinamide mononucleotide oral administration in healthy adult men and women
  13. Dollerup OL, Christensen B, Svart M, Schmidt MS, Sulek K, Ringgaard S, et al. A randomized placebo-controlled clinical trial of nicotinamide riboside in obese men: safety, insulin-sensitivity, and lipid-mobilizing effects. Am J Clin Nutr. 2018;108(2):343-353. A randomized placebo-controlled clinical trial of nicotinamide riboside in obese men: safety, insulin-sensitivity, and lipid-mobilizing effects
  14. Berven H, Kverneng S, Sheard E, Søgnen M, Af Geijerstam SA, Haugarvoll K, et al. NR-SAFE: a randomized, double-blind safety trial of high dose nicotinamide riboside in Parkinson's disease. Nat Commun. 2023;14(1):7793. NR-SAFE: a randomized, double-blind safety trial of high dose nicotinamide riboside in Parkinson's disease
Evidence overview for classes nad precursors: NAD Precursors Billing & Prior-Auth Playbook