NDC 70710-1609-01 - Baclofen

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: 70710-1609
Requested NDC: 70710-1609-01
Package NDCs from labels: 70710-1609-1, 70710-1609-01
Manufacturer: AvPAK
Effective date: 2026-06-29
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Baclofen - AvPAK	AvPAK	2026-06-29	HUMAN PRESCRIPTION DRUG LABEL
Baclofen - American Health Packaging	American Health Packaging	2025-08-04	HUMAN PRESCRIPTION DRUG LABEL
BACLOFEN TABLETS USP Rx only	Zydus Pharmaceuticals (USA) Inc. \| Zydus Lifesciences Global FZE \| Zydus Lifesciences Limited	2024-08-12	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70710-1609-1	Baclofen	100 in 1 BOTTLE	TABLET	100		11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70710-1609	BACLOFEN TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	11	Current NDC, Legacy NDC, 1 package rows	20240815_cfc49176-8d01-4c39-9319-604dd087065c.zip

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 10 · 196 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	ab3760cd-a84b-49ba-88e3-b9ea73c55f82	2026-09-09	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	Atlantic Biologicals Corp.	50b3e7be-832b-313d-e063-6394a90a5ab4	2026-09-04	Warnings, Adverse reactions	Exact identifier unii: H789N3FKE8
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	4e2cd27d-91c7-4f15-96cc-3971769dbeaa	2026-09-03	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	c2e1d183-7061-459b-a631-206b06d12753	2026-09-01	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Par Health USA, LLC	c17527be-661d-42f5-b6f6-56a681ba7870	2026-08-24	Warnings, Adverse reactions	Exact identifier rxcui: 197391 rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	aeb56b0e-7126-4417-b726-e8a54f73de3f	2026-08-24	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	ac9b720f-b755-49f1-9850-efb26feadaeb	2026-08-14	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	355266e4-68f7-47d7-9f4e-1a0fc912786d	2026-08-10	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	REMEDYREPACK INC.	76896b07-2835-4467-b386-87ec66ddd88e	2026-08-04	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	Cardinal Health 107, LLC	3c87e116-871d-46b8-897b-fc27a17b988d	2026-07-24	Warnings, Adverse reactions	Exact identifier application number: ANDA211659 rxcui: 430902 unii: H789N3FKE8
Baclofen	BACLOFEN	Preferred Pharmaceuticals Inc.	3047613d-006b-4011-b5fe-098588f474aa	2026-07-22	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	REMEDYREPACK INC.	6274e70a-fb57-461b-b1bc-39d4ff916b2a	2026-07-14	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	REMEDYREPACK INC.	ebbfec9e-621c-4d04-8a1c-81d2eb9e9c74	2026-06-30	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	AvPAK	c21095a9-17b1-555a-e053-2a95a90a51fd	2026-06-29	Warnings, Adverse reactions	Exact identifier application number: ANDA211659 ndc (package): 50268-105-11 ndc (package): 50268-105-15 ndc (product): 50268-105 rxcui: 430902 spl id: 556dbede-6265-358e-e063-6394a90a4285 spl set id: c21095a9-17b1-555a-e053-2a95a90a51fd unii: H789N3FKE8
BACLOFEN	BACLOFEN	NuCare Pharmaceuticals, Inc.	2517f71f-f452-1f56-e063-6394a90a6ef1	2026-06-25	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
BACLOFEN	BACLOFEN	Redpharm Drug	53df4b4b-842e-9e3a-e063-6394a90a8a3d	2026-06-10	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	REMEDYREPACK INC.	d689d32c-12a7-4ae4-afc3-8a353be67148	2026-06-01	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	Eywa Pharma Inc	7ec59f6b-7c4f-432d-ba27-442861806b6c	2026-05-16	Warnings, Adverse reactions	Exact identifier rxcui: 197391 rxcui: 430902 rxcui: 197392 unii: H789N3FKE8
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	e017a001-8cb1-4dd8-960e-c6d74005f57f	2026-05-12	Warnings, Adverse reactions	Exact identifier rxcui: 430902 unii: H789N3FKE8
Gablofen	BACLOFEN INJECTION	Piramal Critical Care Inc	00d3e846-dd92-448d-9ab8-6a07be823cc1	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: H789N3FKE8

Reported adverse events (FAERS/openFDA)#

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