What is NDC 68382-775?

68382-775 is the product NDC for Methotrexate, Methotrexate 2.5 mg/1 tablet, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Methotrexate?

51 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Methotrexate NDC 68382-775 | National Drug Code

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	6838207750168382077501	100 TABLET in 1 BOTTLE (68382-775-01)Marketed from Feb 9, 2017
68382-775-05	6838207750568382077505	500 TABLET in 1 BOTTLE (68382-775-05)Marketed from Feb 9, 2017
68382-775-10	6838207751068382077510	1000 TABLET in 1 BOTTLE (68382-775-10)Marketed from Feb 9, 2017
68382-775-16	6838207751668382077516	90 TABLET in 1 BOTTLE (68382-775-16)Marketed from Feb 9, 2017
68382-775-60	6838207756068382077560	36 TABLET in 1 BOTTLE (68382-775-60)Marketed from Feb 9, 2017
68382-775-77	6838207757768382077577	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.NDC labeler code 68382
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)

About NDC 68382-775

What is NDC 68382-775?: 68382-775 is the product NDC for Methotrexate, Methotrexate 2.5 mg/1 tablet, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Methotrexate.
What is the active ingredient?: Methotrexate.
Who is the labeler?: Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Methotrexate?: 51 other product NDCs are listed under this name. See all Methotrexate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Methotrexate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Methotrexate	Methotrexate 2.5 mg/1	TabletOral	American Health Packaging	60687-975	60687-0975-94
Methotrexate	Methotrexate sodium 25 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Alembic Pharmaceuticals Limited	46708-711	46708-0711-05
Methotrexate	Methotrexate sodium 25 mg/mL	Injection, SolutionIntramuscular, Intrathecal, Intravenous, Subcutaneous	Alembic Pharmaceuticals Limited	46708-712	46708-0712-01
Methotrexate	Methotrexate sodium 25 mg/mL	Injection, SolutionIntramuscular, Intravenous, Subcutaneous	Alembic Pharmaceuticals Inc.	62332-711	62332-0711-05
Methotrexate	Methotrexate sodium 25 mg/mL	Injection, SolutionIntramuscular, Intrathecal, Intravenous, Subcutaneous	Alembic Pharmaceuticals Inc.	62332-712	62332-0712-01
Methotrexate	Methotrexate 2.5 mg/1	TabletOral	AvPAK	50268-554	50268-0554-15
Methotrexate	Methotrexate sodium 2.5 mg/1	TabletOral	Safecor Health LLC	48433-065	48433-0065-05
Methotrexate	Methotrexate sodium 2.5 mg/1	TabletOral	Coupler LLC	67046-1524	67046-1524-03
Methotrexate	Methotrexate sodium 25 mg/mL	Injection, SolutionIntramuscular, Intrathecal, Intravenous, Subcutaneous	Hospira, Inc.	61703-161	61703-0161-05
Methotrexate	Methotrexate sodium 50 mg/2mL	Injection, SolutionIntramuscular, Intrathecal, Intravenous, Subcutaneous	Eugia US LLC	55150-510	55150-0510-0155150-0510-05

All 52 Methotrexate NDCs

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	Major Pharmaceuticals	0904-7141
Methotrexate	Methotrexate 2.5 mg/1	TabletOral	AvPAK	50268-554
Methotrexate	Methotrexate 2.5 mg/1	TabletOral	American Health Packaging	60687-975
Methotrexate	Methotrexate 2.5 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1058