Home NDC 72603-609-01 Primidone
Product NDC 72603-609
Requested package NDC 72603-609-01
11-digit product format 726030609
Labeler code 72603
Product ID 72603-609_35a3d3c5-7ece-bbd8-e063-6394a90a14aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Primidone
Dosage form TABLET
Route ORAL
Labeler NorthStar Rx LLC
Application ANDA214896
Marketing category ANDA
Marketing start 2025-05-01
Substance PRIMIDONE
Active strength 50 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214896-001 PRIMIDONE PRIMIDONE 50MG TABLET / ORAL AB 2022-06-28 A214896-002 PRIMIDONE PRIMIDONE 250MG TABLET / ORAL AB 2022-06-28 A214896-003 PRIMIDONE PRIMIDONE 125MG TABLET / ORAL 2022-12-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 80 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A214896-001 PRIMIDONE 50MG TABLET / ORAL AB 2022-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214896-002 PRIMIDONE 250MG TABLET / ORAL AB 2022-06-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214896-003 PRIMIDONE 125MG TABLET / ORAL 2022-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214896-001 PRIMIDONE 50MG TABLET / ORAL AB 2022-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214896-002 PRIMIDONE 250MG TABLET / ORAL AB 2022-06-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214896-003 PRIMIDONE 125MG TABLET / ORAL 2022-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214896-001 PRIMIDONE 50MG TABLET / ORAL AB 2022-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214896-002 PRIMIDONE 250MG TABLET / ORAL AB 2022-06-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214896-003 PRIMIDONE 125MG TABLET / ORAL 2022-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214896-001 PRIMIDONE 50MG TABLET / ORAL AB 2022-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214896-002 PRIMIDONE 250MG TABLET / ORAL AB 2022-06-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214896-003 PRIMIDONE 125MG TABLET / ORAL 2022-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214896-001 PRIMIDONE 50MG TABLET / ORAL AB 2022-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214896-002 PRIMIDONE 250MG TABLET / ORAL AB 2022-06-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214896-003 PRIMIDONE 125MG TABLET / ORAL 2022-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214896-001 PRIMIDONE 50MG TABLET / ORAL AB 2022-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214896-002 PRIMIDONE 250MG TABLET / ORAL AB 2022-06-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214896-003 PRIMIDONE 125MG TABLET / ORAL 2022-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214896-001 PRIMIDONE 50MG TABLET / ORAL AB 2022-06-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214896-002 PRIMIDONE 250MG TABLET / ORAL AB 2022-06-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214896-003 PRIMIDONE 125MG TABLET / ORAL 2022-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214896-001 PRIMIDONE 50MG TABLET / ORAL AB 2022-06-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214896-002 PRIMIDONE 250MG TABLET / ORAL AB 2022-06-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214896-003 PRIMIDONE 125MG TABLET / ORAL 2022-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214896-001 PRIMIDONE 50MG TABLET / ORAL AB 2022-06-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214896-002 PRIMIDONE 250MG TABLET / ORAL AB 2022-06-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214896-003 PRIMIDONE 125MG TABLET / ORAL 2022-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214896-001 PRIMIDONE 50MG TABLET / ORAL AB 2022-06-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214896-002 PRIMIDONE 250MG TABLET / ORAL AB 2022-06-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214896-003 PRIMIDONE 125MG TABLET / ORAL 2022-12-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214896-001 PRIMIDONE 50MG TABLET / ORAL AB 2022-06-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214896-002 PRIMIDONE 250MG TABLET / ORAL AB 2022-06-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214896-003 PRIMIDONE 125MG TABLET / ORAL 2022-12-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214896-001 PRIMIDONE 50MG TABLET / ORAL AB 2022-06-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214896-002 PRIMIDONE 250MG TABLET / ORAL AB 2022-06-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214896-003 PRIMIDONE 125MG TABLET / ORAL 2022-12-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214896-001 PRIMIDONE 50MG TABLET / ORAL AB 2022-06-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214896-002 PRIMIDONE 250MG TABLET / ORAL AB 2022-06-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214896-003 PRIMIDONE 125MG TABLET / ORAL 2022-12-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214896-001 PRIMIDONE 50MG TABLET / ORAL AB 2022-06-28 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 58 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Primidone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRIMIDONE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 13AFD7670Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 96304 Internal RxNorm lookup 198150 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72603-609-01 Primidone 100 in 1 BOTTLE TABLET 100 1 72603-609-02 Primidone 500 in 1 BOTTLE TABLET 500 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72603-609 PRIMIDONE TABLET [NORTHSTAR RX LLC] 1 Current NDC, 2 package rows 20250523_182a424b-d142-48c9-996b-059c0885f528.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 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72603-609-01 72603060901 100 TABLET in 1 BOTTLE (72603-609-01) 100 tablet 2025-05-01 No No Current