Methotrexate NDC 16729-486

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-486Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0486Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
16729-486-01	16729048601	100 TABLET in 1 BOTTLE (16729-486-01)Marketed from Aug 24, 2020

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Methotrexate
Generic name (nonproprietary): methotrexate
Active ingredients: Methotrexate sodium — 2.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Accord Healthcare Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213343
Marketing start: Aug 24, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Folic Acid Metabolism Inhibitors (Mechanism)
Identifiers: Product ID 16729-486_52d366f6-f339-ff1a-e063-6294a90a1577SPL ID 52d366f6-f339-ff1a-e063-6294a90a1577SPL set ID 874c7f43-a3be-4236-89cc-24c44e3c5813RxCUI 105585UNII 3IG1E710ZN
Pharmacologic class: Folate Analog Metabolic Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N416729048601 followed by a unit qualifier and the quantity

Package 16729-0486-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective May 27, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Methotrexate tablets is a dihydrofolate reductase inhibitor indicated for the: Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen ( 1.1 ) Treatment of adults with mycosis fungoides ( 1.1 ) Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen ( 1.1 ) Treatment of adults with rheumatoid arthritis ( 1.2 ) Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) ( 1.3 ) Treatment of adults with severe psoriasis ( 1.4 ) 1.1 Neoplastic Diseases is indicated for the: Methotrexate Tablets is indicated for the: treatment o…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213343

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 213343
Product	Strength	Form · route	Labeler	Product NDC
Methotrexate	Methotrexate sodium 2.5 mg/1	TabletOral	Proficient Rx LP	82804-136
Methotrexate	Methotrexate sodium 2.5 mg/1	TabletOral	Bryant Ranch Prepack	71335-1772
Methotrexate	Methotrexate sodium 2.5 mg/1	TabletOral	Coupler LLC	67046-1524
Methotrexate	Methotrexate sodium 2.5 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3991