Home NDC 80005-118 Primidone
Product NDC 80005-118
11-digit product format 800050118
Labeler code 80005
Product ID 80005-118_1f77f842-e0b6-4659-beee-0bb01da839e3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Primidone
Dosage form TABLET
Route ORAL
Labeler Carnegie Pharmaceuticals LLC
Application ANDA218366
Marketing category ANDA
Marketing start 2024-05-01
Substance PRIMIDONE
Active strength 250 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218366-001 PRIMIDONE PRIMIDONE 50MG TABLET / ORAL AB 2024-01-23 A218366-002 PRIMIDONE PRIMIDONE 250MG TABLET / ORAL AB 2024-01-23
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.
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 A218366-001 PRIMIDONE 50MG TABLET / ORAL AB 2024-01-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218366-002 PRIMIDONE 250MG TABLET / ORAL AB 2024-01-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218366-001 PRIMIDONE 50MG TABLET / ORAL AB 2024-01-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218366-002 PRIMIDONE 250MG TABLET / ORAL AB 2024-01-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218366-001 PRIMIDONE 50MG TABLET / ORAL AB 2024-01-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218366-002 PRIMIDONE 250MG TABLET / ORAL AB 2024-01-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218366-001 PRIMIDONE 50MG TABLET / ORAL AB 2024-01-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218366-002 PRIMIDONE 250MG TABLET / ORAL AB 2024-01-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218366-001 PRIMIDONE 50MG TABLET / ORAL AB 2024-01-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218366-002 PRIMIDONE 250MG TABLET / ORAL AB 2024-01-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218366-001 PRIMIDONE 50MG TABLET / ORAL AB 2024-01-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218366-002 PRIMIDONE 250MG TABLET / ORAL AB 2024-01-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218366-001 PRIMIDONE 50MG TABLET / ORAL AB 2024-01-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218366-002 PRIMIDONE 250MG TABLET / ORAL AB 2024-01-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218366-001 PRIMIDONE 50MG TABLET / ORAL AB 2024-01-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218366-002 PRIMIDONE 250MG TABLET / ORAL AB 2024-01-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218366-001 PRIMIDONE 50MG TABLET / ORAL AB 2024-01-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218366-002 PRIMIDONE 250MG TABLET / ORAL AB 2024-01-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218366-001 PRIMIDONE 50MG TABLET / ORAL AB 2024-01-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218366-002 PRIMIDONE 250MG TABLET / ORAL AB 2024-01-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218366-001 PRIMIDONE 50MG TABLET / ORAL AB 2024-01-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218366-002 PRIMIDONE 250MG TABLET / ORAL AB 2024-01-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218366-001 PRIMIDONE 50MG TABLET / ORAL AB 2024-01-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218366-002 PRIMIDONE 250MG TABLET / ORAL AB 2024-01-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218366-001 PRIMIDONE 50MG TABLET / ORAL AB 2024-01-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218366-002 PRIMIDONE 250MG TABLET / ORAL AB 2024-01-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218366-001 PRIMIDONE 50MG TABLET / ORAL AB 2024-01-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A218366-002 PRIMIDONE 250MG TABLET / ORAL AB 2024-01-23 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A218366-001 PRIMIDONE 50MG TABLET / ORAL AB 2024-01-23 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A218366-002 PRIMIDONE 250MG TABLET / ORAL AB 2024-01-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A218366-001 PRIMIDONE 50MG TABLET / ORAL AB 2024-01-23 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A218366-002 PRIMIDONE 250MG TABLET / ORAL AB 2024-01-23 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218366-001 PRIMIDONE 50MG TABLET / ORAL AB 2024-01-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218366-002 PRIMIDONE 250MG TABLET / ORAL AB 2024-01-23 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Primidone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRIMIDONE 250 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 80005-118-11 Primidone 100 in 1 BOTTLE TABLET 100 4 80005-118-14 Primidone 500 in 1 BOTTLE TABLET 500 4 80005-118-15 Primidone 1000 in 1 BOTTLE TABLET 1000 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80005-118 PRIMIDONE TABLET [CARNEGIE PHARMACEUTICALS LLC] 4 Current NDC, 3 package rows 20240704_dc018b1d-72d3-45a2-84ff-cf9499c7ae97.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 · 1 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 80005-118-11 80005011811 100 TABLET in 1 BOTTLE (80005-118-11) 100 tablet 2024-05-01 No No Current 80005-118-14 80005011814 500 TABLET in 1 BOTTLE (80005-118-14) 500 tablet 2024-05-01 No No Current 80005-118-15 80005011815 1000 TABLET in 1 BOTTLE (80005-118-15) 1000 tablet 2024-05-01 No No Current