Home NDC 55111-476 Primidone
Product NDC 55111-476
11-digit product format 551110476
Labeler code 55111
Product ID 55111-476_6f5c36d3-3f99-803c-5be6-66b2e1058946
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Primidone
Dosage form TABLET
Route ORAL
Labeler Dr. Reddy's Laboratories Limited
Application ANDA040862
Marketing category ANDA
Marketing start 2008-10-03
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 42 .
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 A040862-001 PRIMIDONE PRIMIDONE 50MG TABLET / ORAL 2008-10-03 A040862-002 PRIMIDONE PRIMIDONE 250MG TABLET / ORAL 2008-10-03
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 3 · 84 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 2026-08-18 06:07:40 2026-07 A040862-001 PRIMIDONE 50MG TABLET / ORAL 2008-10-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040862-002 PRIMIDONE 250MG TABLET / ORAL 2008-10-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040862-001 PRIMIDONE 50MG TABLET / ORAL 2008-10-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040862-002 PRIMIDONE 250MG TABLET / ORAL 2008-10-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040862-001 PRIMIDONE 50MG TABLET / ORAL 2008-10-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040862-002 PRIMIDONE 250MG TABLET / ORAL 2008-10-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040862-001 PRIMIDONE 50MG TABLET / ORAL 2008-10-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040862-002 PRIMIDONE 250MG TABLET / ORAL 2008-10-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040862-001 PRIMIDONE 50MG TABLET / ORAL 2008-10-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040862-002 PRIMIDONE 250MG TABLET / ORAL 2008-10-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040862-001 PRIMIDONE 50MG TABLET / ORAL 2008-10-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040862-002 PRIMIDONE 250MG TABLET / ORAL 2008-10-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040862-001 PRIMIDONE 50MG TABLET / ORAL 2008-10-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040862-002 PRIMIDONE 250MG TABLET / ORAL 2008-10-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040862-001 PRIMIDONE 50MG TABLET / ORAL 2008-10-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040862-002 PRIMIDONE 250MG TABLET / ORAL 2008-10-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040862-001 PRIMIDONE 50MG TABLET / ORAL 2008-10-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040862-002 PRIMIDONE 250MG TABLET / ORAL 2008-10-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040862-001 PRIMIDONE 50MG TABLET / ORAL 2008-10-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040862-002 PRIMIDONE 250MG TABLET / ORAL 2008-10-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040862-001 PRIMIDONE 50MG TABLET / ORAL 2008-10-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040862-002 PRIMIDONE 250MG TABLET / ORAL 2008-10-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040862-001 PRIMIDONE 50MG TABLET / ORAL 2008-10-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040862-002 PRIMIDONE 250MG TABLET / ORAL 2008-10-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040862-001 PRIMIDONE 50MG TABLET / ORAL 2008-10-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040862-002 PRIMIDONE 250MG TABLET / ORAL 2008-10-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040862-001 PRIMIDONE 50MG TABLET / ORAL 2008-10-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040862-002 PRIMIDONE 250MG TABLET / ORAL 2008-10-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040862-001 PRIMIDONE 50MG TABLET / ORAL 2008-10-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A040862-002 PRIMIDONE 250MG TABLET / ORAL 2008-10-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040862-001 PRIMIDONE 50MG TABLET / ORAL 2008-10-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040862-002 PRIMIDONE 250MG TABLET / ORAL 2008-10-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040862-001 PRIMIDONE 50MG TABLET / ORAL 2008-10-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A040862-002 PRIMIDONE 250MG TABLET / ORAL 2008-10-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040862-001 PRIMIDONE 50MG TABLET / ORAL 2008-10-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A040862-002 PRIMIDONE 250MG TABLET / ORAL 2008-10-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040862-001 PRIMIDONE 50MG TABLET / ORAL 2008-10-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040862-002 PRIMIDONE 250MG TABLET / ORAL 2008-10-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040862-001 PRIMIDONE 50MG TABLET / ORAL 2008-10-03 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040862-002 PRIMIDONE 250MG TABLET / ORAL 2008-10-03 bb7c543d1eb4…
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# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-476 PRIMIDONE TABLET [DR. REDDY'S LABORATORIES LIMITED] 3 Current NDC, Legacy NDC, 6 package rows 20171206_a4f917f4-2aa2-c3ed-071e-232fa0f125e8.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 Marketing end Sample Exclude flag Status 55111-476-01 55111047601 100 TABLET in 1 BOTTLE (55111-476-01) 100 tablet 2008-10-03 0000-00-00 No No Current 55111-476-05 55111047605 500 TABLET in 1 BOTTLE (55111-476-05) 500 tablet 2008-10-03 0000-00-00 No No Current 55111-476-30 55111047630 30 TABLET in 1 BOTTLE (55111-476-30) 30 tablet 2008-10-03 0000-00-00 No No Current 55111-476-60 55111047660 60 TABLET in 1 BOTTLE (55111-476-60) 60 tablet 2008-10-03 0000-00-00 No No Current 55111-476-78 55111047678 10 BLISTER PACK in 1 CARTON (55111-476-78) / 10 TABLET in 1 BLISTER PACK (55111-476-79) 10 blister pack 2008-10-03 0000-00-00 No No Current 55111-476-79 55111047679 10 in 1 BLISTER PACK Historical