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 8 of 10 · 195 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Bryant Ranch Prepack	08a6866f-b127-482f-9f22-113175487bdd	2024-09-12	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	5b92b0a6-ebba-4815-8b94-f2014674399b	2024-09-05	Warnings, Adverse reactions	Exact identifier application number: ANDA211659 rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	4634093b-6def-41d6-a7f3-23040125c4f4	2024-09-03	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	655db2a3-daf7-4f4b-8f64-4a6d81fdc165	2024-09-03	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	b5fde991-7d12-4083-a3d6-363718f1f6a1	2024-08-16	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	Zydus Lifesciences Limited	bb5c6faa-2933-44d1-8706-8302150be734	2024-08-12	Warnings, Adverse reactions	Exact identifier application number: ANDA211659 rxcui: 197391 rxcui: 2679605 rxcui: 430902 rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Zydus Pharmaceuticals (USA) Inc.	cfc49176-8d01-4c39-9319-604dd087065c	2024-08-12	Warnings, Adverse reactions	Exact identifier application number: ANDA211659 ndc (package): 70710-1285-1 ndc (package): 70710-1609-1 ndc (package): 70710-1666-1 ndc (package): 70710-1285-0 ndc (package): 70710-1286-1 ndc (package): 70710-1285-5 ndc (package): 70710-1286-5 ndc (package): 70710-1286-0 ndc (product): 70710-1666 ndc (product): 70710-1609 ndc (product): 70710-1285 ndc (product): 70710-1286 ndc11 (package): 70710160901 rxcui: 197391 rxcui: 2679605 rxcui: 430902 rxcui: 197392 spl id: f96d29a2-071a-4a33-a57e-bb55eba0d660 spl set id: cfc49176-8d01-4c39-9319-604dd087065c unii: H789N3FKE8
Baclofen	BACLOFEN	NuCare Pharmaceuticals,Inc.	b2be2e6c-a247-30f4-e053-2a95a90a6ccb	2024-07-17	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	Direct_rx	1bf59c3b-f8eb-972e-e063-6394a90aeccc	2024-06-28	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	9834e409-8633-4f99-8ac7-7fa298d01c44	2024-05-30	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	19b049cf-56a4-aeaa-e063-6394a90a366d	2024-05-30	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	adc072b9-e48b-470d-9eb1-fd7b52c1f122	2024-05-29	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
BACLOFEN	BACLOFEN	TruPharma LLC	68aa591e-ea98-4438-9a4a-4f7e9ea2b285	2024-04-17	Warnings, Adverse reactions	Exact identifier rxcui: 197391 rxcui: 2679605 rxcui: 430902 rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	d24135b3-e247-412f-a10b-ceecbdee3aef	2024-04-02	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	80a4c6f7-4f02-493c-9263-62e1c90404ba	2024-04-02	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Pure Cornstarch Baby	CORN STARCH	Walgreen Company	d0e9bd13-b568-4f7e-b036-8d23e71ad8bf	2024-03-25	Warnings	Exact identifier unii: O8232NY3SJ
BACLOFEN	BACLOFEN	Rising Pharma Holdings, Inc.	6eb46715-d72b-473f-b984-90024033d4a0	2024-03-01	Warnings, Adverse reactions	Exact identifier rxcui: 197391 rxcui: 430902 rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	7f27f935-b1fa-4494-9014-7f62c59bb8e3	2024-01-30	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	fc4b99b3-f59f-4e1f-9a8c-123a0c2fbd9f	2024-01-30	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	Bryant Ranch Prepack	402a0a2b-95a6-4d22-bedf-826e1f1cd2c3	2024-01-11	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8

Reported adverse events (FAERS/openFDA)#

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