Methotrexate NDC 68382-775

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-775Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0775Add 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
68382-775-01	68382077501	100 TABLET in 1 BOTTLE (68382-775-01)Marketed from Feb 9, 2017
68382-775-05	68382077505	500 TABLET in 1 BOTTLE (68382-775-05)Marketed from Feb 9, 2017
68382-775-10	68382077510	1000 TABLET in 1 BOTTLE (68382-775-10)Marketed from Feb 9, 2017
68382-775-16	68382077516	90 TABLET in 1 BOTTLE (68382-775-16)Marketed from Feb 9, 2017
68382-775-60	68382077560	36 TABLET in 1 BOTTLE (68382-775-60)Marketed from Feb 9, 2017
68382-775-77	68382077577	100 BLISTER PACK in 1 CARTON (68382-775-77) / 1 TABLET in 1 BLISTER PACKMarketed from Feb 9, 2017

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 — 2.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Zydus Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207812
Marketing start: Feb 9, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Folic Acid Metabolism Inhibitors (Mechanism)
Identifiers: Product ID 68382-775_5d9b7269-19d4-4d2c-b252-f3ff759dffa5SPL ID 5d9b7269-19d4-4d2c-b252-f3ff759dffa5SPL set ID 948e0bab-6524-4b87-9853-1799d4415558RxCUI 105585UNII YL5FZ2Y5U1
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

N468382077501 followed by a unit qualifier and the quantity

Package 68382-0775-01. 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 9, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Methotrexate tablets are 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 Methotrexate tablets are indicated for the: treatment of adults and pediatr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207812

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

FDA NDC Directory listings under ANDA 207812
Product	Strength	Form · route	Labeler	Product NDC
Methotrexate	Methotrexate 2.5 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1058
Methotrexate	Methotrexate 2.5 mg/1	TabletOral	AvPAK	50268-554
Methotrexate	Methotrexate 2.5 mg/1	TabletOral	Major Pharmaceuticals	0904-7141