NDC 68071-3991-09 - Methotrexate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 68071-3991
Requested NDC: 68071-3991-09
Package NDCs from labels: 68071-3991-9, 68071-3991-09
Manufacturer: NuCare Pharmaceuticals, Inc.
Effective date: 2026-04-30
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Methotrexate - NuCare Pharmaceuticals, Inc.	NuCare Pharmaceuticals, Inc.	2026-04-30	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3991-9	Methotrexate	90 in 1 BOTTLE	TABLET	90		1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methotrexate	METHOTREXATE	A-S Medication Solutions	22e10810-16fb-4c84-bccf-972405b77ef8	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 105585 unii: 3IG1E710ZN
Methotrexate	METHOTREXATE	AvKARE	757d6cef-6696-7a1c-8074-01258aaa8bdd	2026-07-23	Boxed warning, Adverse reactions	Exact identifier rxcui: 105585 unii: 3IG1E710ZN
Trexall	METHOTREXATE	Teva Women's Health LLC	e942f8db-510f-44d6-acb5-b822196f5e8c	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 3IG1E710ZN
Methotrexate	METHOTREXATE	Bryant Ranch Prepack	b6e61c50-024a-494f-b04c-100fb371a837	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 105585 unii: 3IG1E710ZN
Methotrexate	METHOTREXATE	Bryant Ranch Prepack	0b54b5c4-2466-4f85-b9a0-ad93ec4a06a1	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 105585 unii: 3IG1E710ZN
Methotrexate	METHOTREXATE	Teva Pharmaceuticals USA, Inc.	9b34b1d8-d125-41a2-9f6f-3fab67b573bd	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 105585 unii: 3IG1E710ZN
Methotrexate	METHOTREXATE	Major Pharmaceuticals	2a6afc4c-819d-4ba9-8040-4504519c116a	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 105585
Methotrexate	METHOTREXATE	Accord Healthcare Inc.	874c7f43-a3be-4236-89cc-24c44e3c5813	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA213343 ndc (product): 16729-486 rxcui: 105585 spl id: 52d366f6-f339-ff1a-e063-6294a90a1577 spl set id: 874c7f43-a3be-4236-89cc-24c44e3c5813 unii: 3IG1E710ZN
METHOTREXATE	METHOTREXATE	Bryant Ranch Prepack	4a04756f-e1c9-4d1e-b309-7be31c9176d6	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 105585 unii: 3IG1E710ZN
Methotrexate Sodium	METHOTREXATE SODIUM	Elite Laboratories, Inc.	89c05ea3-3be1-46dd-b112-29c436fd7289	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 105585 unii: 3IG1E710ZN
Methotrexate	METHOTREXATE SODIUM	Sun Pharmaceutical Industries, Inc.	8f1260de-b60c-4f0e-8af6-0e957b0a281b	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 105585 unii: 3IG1E710ZN
Methotrexate Sodium	METHOTREXATE SODIUM	Hikma Pharmaceuticals USA Inc.	d71b1856-99d8-4a9e-9189-f87b6675f80a	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 105585 unii: 3IG1E710ZN
Methotrexate	METHOTREXATE	Bryant Ranch Prepack	4741a44f-0d0b-4380-84f6-231a8d1560fb	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA213343 rxcui: 105585 unii: 3IG1E710ZN
METHOTREXATE	METHOTREXATE	Alembic Pharmaceuticals Inc.	04a95db9-a124-4b97-bd71-1c37a6b3b0c8	2026-05-18	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 105585 unii: 3IG1E710ZN
Methotrexate	METHOTREXATE	Zydus Pharmaceuticals USA Inc.	948e0bab-6524-4b87-9853-1799d4415558	2026-05-09	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 105585
Methotrexate	METHOTREXATE	Mylan Pharmaceuticals Inc.	70c09984-2b36-424f-8b27-3fd0cd4e833d	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 105585 unii: 3IG1E710ZN
Methotrexate	METHOTREXATE	Aurobindo Pharma Limited	09931d44-a3f8-49dc-a3f2-b527ee4214bf	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 105585 unii: 3IG1E710ZN
Methotrexate	METHOTREXATE	NuCare Pharmaceuticals, Inc.	50b2cfc7-dfe4-4406-e063-6294a90a2527	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA213343 ndc (package): 68071-3991-9 ndc (product): 68071-3991 ndc11 (package): 68071399109 rxcui: 105585 spl id: 50b2d5ac-f9bb-4f80-e063-6294a90a933b spl set id: 50b2cfc7-dfe4-4406-e063-6294a90a2527 unii: 3IG1E710ZN
Caldesene Baby	STARCH, CORN AND ZINC OXIDE	Insight Pharmaceuticals LLC	9f12dee2-7afa-45e9-a729-0fd42bb77715	2026-04-22	Warnings	Exact identifier unii: O8232NY3SJ
Caldesene Medicated Protecting	CORNSTARCH AND ZINC OXIDE	Insight Pharmaceuticals LLC	ffc92a0f-a7cf-4a46-b2f1-089df2bbb96b	2026-04-22	Warnings	Exact identifier unii: O8232NY3SJ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.