NDC 63629-7811-03 - Primidone

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: 63629-7811
Requested NDC: 63629-7811-03
Package NDCs from labels: 63629-7811-1, 63629-7811-2, 63629-7811-3, 63629-7811-03
Manufacturer: Bryant Ranch Prepack
Effective date: 2026-06-24
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Primidone - Bryant Ranch Prepack	Bryant Ranch Prepack	2026-06-24	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2020-10-16	Primidone Tablets, USP (50 mg and 250 mg) Rx only
2020-10-16	Primidone Tablets, USP (50 mg and 250 mg) Rx only
2020-01-31	Primidone Tablets, USP (50 mg and 250 mg) Rx only
2020-01-31	Primidone Tablets, USP (50 mg and 250 mg) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-7811-1	Primidone	30 in 1 BOTTLE	TABLET	30	5
63629-7811-2	Primidone	90 in 1 BOTTLE	TABLET	90	5
63629-7811-3	Primidone	60 in 1 BOTTLE	TABLET	60	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-7811	PRIMIDONE TABLET [BRYANT RANCH PREPACK]	5	Current NDC, Legacy NDC, 3 package rows	20240502_93b4b34c-6dba-4aec-b98e-b2b18feb86a9.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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mysoline	PRIMIDONE	Bausch Health US, LLC	af593171-dabb-4ea3-b44c-89ed457b2c46	2026-09-10	Warnings, Adverse reactions	Exact identifier rxcui: 96304 rxcui: 198150 unii: 13AFD7670Q
Primidone	PRIMIDONE	NCS HealthCare of KY, LLC dba Vangard Labs	14f9aee1-4d3e-45e0-ad5c-70bd98667adc	2026-09-01	Warnings, Adverse reactions	Exact identifier rxcui: 198150 unii: 13AFD7670Q
Primidone	PRIMIDONE	Bryant Ranch Prepack	93b4b34c-6dba-4aec-b98e-b2b18feb86a9	2026-06-24	Warnings, Adverse reactions	Exact identifier application number: ANDA040866 ndc (package): 63629-7811-3 ndc (package): 63629-7811-2 ndc (package): 63629-7811-1 ndc (product): 63629-7811 ndc11 (package): 63629781103 rxcui: 198150 spl id: 7f6c707a-2cd1-4243-8b4c-4d08e04e25e4 spl set id: 93b4b34c-6dba-4aec-b98e-b2b18feb86a9 unii: 13AFD7670Q
Primidone	PRIMIDONE	AvKARE	e7a50a67-9653-463e-8c85-315b53f460c8	2026-05-13	Warnings, Adverse reactions	Exact identifier application number: ANDA040866 rxcui: 96304 rxcui: 198150 unii: 13AFD7670Q
Primidone	PRIMIDONE	Amneal Pharmaceuticals of New York LLC	3cdc361a-5558-4341-ad40-f8bc29b4f1ce	2026-04-02	Warnings, Adverse reactions	Exact identifier application number: ANDA040866 ndc (product): 53746-544 rxcui: 96304 rxcui: 198150 spl id: 574c0bff-04c5-41f0-8d10-315a824d8efd spl set id: 3cdc361a-5558-4341-ad40-f8bc29b4f1ce unii: 13AFD7670Q
Primidone	PRIMIDONE	Actavis Pharma, Inc.	ae0fa704-818e-4423-8e3a-6cc3390cdd7d	2026-02-01	Warnings, Adverse reactions	Exact identifier rxcui: 96304 unii: 13AFD7670Q
Primidone	PRIMIDONE	Advagen Pharma Limited	b3b94d2e-6a64-45b7-b0cb-0fde689240d8	2026-01-13	Warnings, Adverse reactions	Exact identifier rxcui: 96304 rxcui: 198150 unii: 13AFD7670Q
Primidone	PRIMIDONE	Proficient Rx LP	db761e34-8573-4f96-872c-e851b3004e5e	2026-01-01	Warnings, Adverse reactions	Exact identifier rxcui: 96304 rxcui: 198150 unii: 13AFD7670Q
Primidone	PRIMIDONE	Chartwell RX, LLC	4a8e309f-d89e-4b1a-abb2-856a66ebbff9	2025-12-11	Warnings, Adverse reactions	Exact identifier rxcui: 198150 unii: 13AFD7670Q
Primidone	PRIMIDONE	AvPAK	a90d5ba6-4170-0b97-5ae3-fc707c9e4f1b	2025-11-05	Warnings, Adverse reactions	Exact identifier application number: ANDA040866 rxcui: 96304 rxcui: 198150 unii: 13AFD7670Q
Primidone	PRIMIDONE	PD-Rx Pharmaceuticals, Inc.	6046e4e9-0c1e-4d1f-85fa-d2ce25c5dc34	2025-10-20	Warnings, Adverse reactions	Exact identifier rxcui: 96304 rxcui: 198150 unii: 13AFD7670Q
Primidone	PRIMIDONE	PD-Rx Pharmaceuticals, Inc.	0193c0a4-f593-609c-e063-6294a90aaa68	2025-06-10	Warnings, Adverse reactions	Exact identifier rxcui: 96304 rxcui: 198150 unii: 13AFD7670Q
Primidone	PRIMIDONE	NorthStar Rx LLC	182a424b-d142-48c9-996b-059c0885f528	2025-05-21	Warnings, Adverse reactions	Exact identifier rxcui: 96304 rxcui: 198150 unii: 13AFD7670Q
PRIMIDONE	PRIMIDONE	DIRECT RX	c20f803c-e965-9dd8-e053-2995a90a92ba	2025-01-17	Warnings, Adverse reactions	Exact identifier rxcui: 198150 unii: 13AFD7670Q
Primidone	PRIMIDONE	Golden State Medical Supply, Inc	e4e493bd-94d7-7e5a-e053-2995a90a2706	2024-12-23	Warnings, Adverse reactions	Exact identifier rxcui: 96304 rxcui: 198150 unii: 13AFD7670Q
Primidone	PRIMIDONE	Amneal Pharmaceuticals LLC	02ba0182-0870-4c0d-a814-a1dc427d47b8	2024-10-30	Warnings, Adverse reactions	Exact identifier application number: ANDA040866 rxcui: 96304 rxcui: 198150 unii: 13AFD7670Q
Primidone	PRIMIDONE	American Health Packaging	a32e0a00-3ba7-47e7-83c6-a7eac5fbdd11	2024-10-03	Warnings, Adverse reactions	Exact identifier rxcui: 96304 rxcui: 198150 unii: 13AFD7670Q
Primidone	PRIMIDONE	Carnegie Pharmaceuticals LLC	dc018b1d-72d3-45a2-84ff-cf9499c7ae97	2024-06-05	Warnings, Adverse reactions	Exact identifier rxcui: 96304 rxcui: 198150 unii: 13AFD7670Q
Primidone	PRIMIDONE	Bryant Ranch Prepack	5067ff85-07f5-424c-b072-6907891e7b4e	2024-05-23	Warnings, Adverse reactions	Exact identifier rxcui: 198150 unii: 13AFD7670Q
Primidone	PRIMIDONE	Aphena Pharma Solutions - Tennessee, LLC	ad8b50e2-e797-4326-a57e-d254da85b6b9	2024-01-09	Warnings, Adverse reactions	Exact identifier rxcui: 198150 unii: 13AFD7670Q

Reported adverse events (FAERS/openFDA)#

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