NDC 21695-014-30 - 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: 21695-014
Requested NDC: 21695-014-30
Package NDCs from labels: 21695-014-30, 21695-014-42, 21695-014-60, 21695-014-90, 21695-014-72
Manufacturer: Rebel Distributors Corp.
Effective date: 2009-12-01
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Baclofen Tablets USP 10mg & 20mg	Rebel Distributors Corp.	2009-12-01	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-014-42	2019-09-24	C162847	48780-1	934fe258-4c6e-48b1-e053-8cdaa90a720a	Baclofen Tablets USP 10mg & 20mg
21695-014-72	2019-09-24	C162847	48780-1	934fe258-4c6e-48b1-e053-8cdaa90a720a	Baclofen Tablets USP 10mg & 20mg
21695-014-90	2019-09-24	C162847	48780-1	934fe258-4c6e-48b1-e053-8cdaa90a720a	Baclofen Tablets USP 10mg & 20mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
21695-014-30	Baclofen	30 in 1 BOTTLE	TABLET	30	1
21695-014-42	Baclofen	42 in 1 BOTTLE	TABLET	42	1
21695-014-60	Baclofen	60 in 1 BOTTLE	TABLET	60	1
21695-014-72	Baclofen	120 in 1 BOTTLE	TABLET	120	1
21695-014-90	Baclofen	90 in 1 BOTTLE	TABLET	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-014	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 5 package rows	20100329_d88886cc-62c0-44dd-8a3f-cac601832d8e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-014-30	EA - Each	21695-014	045b5479-8a48-4d8c-9230-f5d2a183b569	1	2012-07-24
21695-014-60	EA - Each	21695-014	f974850f-d5fd-43d0-8ba4-4c7e7a277577	1	2012-07-24
21695-014-72	EA - Each	21695-014	67d2f2c6-d0bc-41c7-872b-eb0966b54255	1	2012-07-24
21695-014-90	EA - Each	21695-014	10ba6395-b45c-47ec-8f19-96e039588df3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BACLOFEN	ACTIVE INGREDIENT	H789N3FKE8	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1
BACLOFEN	ACTIVE MOIETY	H789N3FKE8	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BACLOFEN TABLET [REBEL DISTRIBUTORS CORP.]	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 3 of 12 · 235 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BACLOFEN	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	ee59a379-17d5-487f-b72f-a53e74744a70	2026-03-27	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
BACLOFEN	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	91175128-8285-4d04-89a9-219781be9260	2026-03-25	Warnings, Adverse reactions	Exact identifier unii: H789N3FKE8
BACLOFEN	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	16266972-843e-4ea5-be1f-fb1b1588a5dc	2026-03-25	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
BACLOFEN	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	0a1d09ac-94d5-45ef-92cc-bc261c2b2d75	2026-03-25	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	A-S Medication Solutions	4f84b27a-725a-48e6-a58a-85bbb395f4ae	2026-03-23	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
BACLOFEN	BACLOFEN	Preferred Pharmaceuticals Inc.	d20cc8b2-5236-4c87-b395-0acaaf7b62dd	2026-03-19	Warnings, Adverse reactions	Exact identifier rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	A-S Medication Solutions	5f6a86f9-9658-4210-a47c-62907edfd416	2026-03-19	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
BACLOFEN	BACLOFEN	Preferred Pharmaceuticals Inc.	5e479876-adfb-4590-ac10-3924ff7988b0	2026-03-18	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
BACLOFEN	BACLOFEN	Preferred Pharmaceuticals Inc.	3fdfeef9-68b3-4f6c-a4de-28179758a962	2026-03-18	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
Baclofen	BACLOFEN	Redpharm Drug	4ce1de84-72e1-57d3-e063-6294a90a220f	2026-03-13	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
OZOBAX DS	BACLOFEN	Rosemont Pharmaceuticals LLC	d8ddcec5-debe-42b4-a803-e65917cc6a54	2026-03-13	Warnings, Adverse reactions	Exact identifier unii: H789N3FKE8
Leader Advanced Relief Eye Drops	DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Cardinal Health	5c5d6c13-9b51-48f0-8627-b60b0f707fd3	2026-03-12	Warnings	Exact identifier unii: FZ989GH94E
Baclofen	BACLOFEN	Lifestar Pharma LLC	f9dd1b55-2984-446a-8146-2ab0f5211e15	2026-02-27	Warnings, Adverse reactions	Exact identifier rxcui: 197391 rxcui: 197392 unii: H789N3FKE8
Baclofen	BACLOFEN	A-S Medication Solutions	7ee42a29-21c2-47f8-a5b3-f3af115b665d	2026-02-24	Warnings, Adverse reactions	Exact identifier rxcui: 197391 unii: H789N3FKE8
BACLOFEN	BACLOFEN	Major Pharmaceuticals	46f84504-ffc4-4be5-9598-c20a3f4210f4	2026-02-13	Warnings, Adverse reactions	Exact identifier unii: H789N3FKE8
GoodSense Eye Drops Advanced Relief Moisturizer	DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Sportpharm LLC	8d58dcbb-72a0-41f0-9eeb-613072a6d7ae	2026-02-06	Warnings	Exact identifier unii: FZ989GH94E
Baclofen	BACLOFEN	Bryant Ranch Prepack	80b0a41e-2cad-4e14-9605-0cd35f9991e9	2026-02-05	Warnings, Adverse reactions	Exact identifier unii: H789N3FKE8
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	7df6e691-f1d5-441c-b5bb-a3867983e09f	2026-02-05	Warnings, Adverse reactions	Exact identifier unii: H789N3FKE8
MINIDROPS	LUBRICANT EYE DROPS	Optics Laboratory, Inc	c13c5f91-50df-471c-a7c9-1747a2ac1250	2026-02-03	Warnings	Exact identifier unii: FZ989GH94E
Baclofen	BACLOFEN	Preferred Pharmaceuticals, Inc.	58416ceb-994f-4571-afbd-c2171823f528	2026-01-26	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.