NDC 71335-1965-02 - 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
- 71335-1965
- Requested NDC
- 71335-1965-02
- Package NDCs from labels
- 71335-1965-1, 71335-1965-2, 71335-1965-3, 71335-1965-02
- Manufacturer
- Bryant Ranch Prepack
- Effective date
- 2024-05-23
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Primidone - Bryant Ranch Prepack | Bryant Ranch Prepack | 2024-05-23 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 71335-1965-1 | Primidone | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 103 | |
| 71335-1965-2 | Primidone | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | 103 | |
| 71335-1965-3 | Primidone | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | 103 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 71335-1965 | PRIMIDONE TABLET [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 3 package rows | 20240524_5067ff85-07f5-424c-b072-6907891e7b4e.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.
| 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 | 96304 198150 13AFD7670Q |
| Primidone | PRIMIDONE | NCS HealthCare of KY, LLC dba Vangard Labs | 14f9aee1-4d3e-45e0-ad5c-70bd98667adc | 2026-09-01 | Warnings, Adverse reactions | ANDA040586 198150 13AFD7670Q |
| Primidone | PRIMIDONE | Bryant Ranch Prepack | 93b4b34c-6dba-4aec-b98e-b2b18feb86a9 | 2026-06-24 | Warnings, Adverse reactions | 198150 13AFD7670Q |
| Primidone | PRIMIDONE | AvKARE | e7a50a67-9653-463e-8c85-315b53f460c8 | 2026-05-13 | Warnings, Adverse reactions | 96304 198150 13AFD7670Q |
| Primidone | PRIMIDONE | Amneal Pharmaceuticals of New York LLC | 3cdc361a-5558-4341-ad40-f8bc29b4f1ce | 2026-04-02 | Warnings, Adverse reactions | 96304 198150 13AFD7670Q |
| Primidone | PRIMIDONE | Actavis Pharma, Inc. | ae0fa704-818e-4423-8e3a-6cc3390cdd7d | 2026-02-01 | Warnings, Adverse reactions | 96304 13AFD7670Q |
| Primidone | PRIMIDONE | Advagen Pharma Limited | b3b94d2e-6a64-45b7-b0cb-0fde689240d8 | 2026-01-13 | Warnings, Adverse reactions | 96304 198150 13AFD7670Q |
| Primidone | PRIMIDONE | Proficient Rx LP | db761e34-8573-4f96-872c-e851b3004e5e | 2026-01-01 | Warnings, Adverse reactions | ANDA040586 96304 198150 13AFD7670Q |
| Primidone | PRIMIDONE | Chartwell RX, LLC | 4a8e309f-d89e-4b1a-abb2-856a66ebbff9 | 2025-12-11 | Warnings, Adverse reactions | 198150 13AFD7670Q |
| Primidone | PRIMIDONE | AvPAK | a90d5ba6-4170-0b97-5ae3-fc707c9e4f1b | 2025-11-05 | Warnings, Adverse reactions | 96304 198150 13AFD7670Q |
| Primidone | PRIMIDONE | PD-Rx Pharmaceuticals, Inc. | 6046e4e9-0c1e-4d1f-85fa-d2ce25c5dc34 | 2025-10-20 | Warnings, Adverse reactions | ANDA040586 96304 198150 13AFD7670Q |
| TRIMO SAN | OXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATE | CooperSurgical, Inc. | 1e4a1caa-e6ba-44ef-8347-07e6385a7c9e | 2025-09-03 | Warnings | 368GB5141J |
| Steritalc 2g | TALC | Novatech SA | c94e51d9-beef-4b06-e053-2a95a90a754a | 2025-06-25 | Warnings, Adverse reactions | 7SEV7J4R1U |
| SENSITIVE POCKET SUN | SENSITIVE POCKET SUN | Shantou Oushiya Biotechnology Co., Ltd | 36ac412f-e31f-6906-e063-6394a90a4a3d | 2025-06-14 | Warnings | 7SEV7J4R1U |
| Primidone | PRIMIDONE | PD-Rx Pharmaceuticals, Inc. | 0193c0a4-f593-609c-e063-6294a90aaa68 | 2025-06-10 | Warnings, Adverse reactions | ANDA040586 96304 198150 13AFD7670Q |
| Primidone | PRIMIDONE | NorthStar Rx LLC | 182a424b-d142-48c9-996b-059c0885f528 | 2025-05-21 | Warnings, Adverse reactions | 96304 198150 13AFD7670Q |
| PRIMIDONE | PRIMIDONE | DIRECT RX | c20f803c-e965-9dd8-e053-2995a90a92ba | 2025-01-17 | Warnings, Adverse reactions | ANDA040586 198150 13AFD7670Q |
| Primidone | PRIMIDONE | Golden State Medical Supply, Inc | e4e493bd-94d7-7e5a-e053-2995a90a2706 | 2024-12-23 | Warnings, Adverse reactions | 96304 198150 13AFD7670Q |
| Household Antigens | ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUM | Energique, Inc. | f3db63df-62a4-48d6-92e7-94e4a5701552 | 2024-12-20 | Warnings | 368GB5141J |
| Primidone | PRIMIDONE | Amneal Pharmaceuticals LLC | 02ba0182-0870-4c0d-a814-a1dc427d47b8 | 2024-10-30 | Warnings, Adverse reactions | 96304 198150 13AFD7670Q |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.