Home NDC 69452-209 Nimodipine
Product NDC 69452-209
11-digit product format 694520209
Labeler code 69452
Product ID 69452-209_452704d5-dbeb-5833-e063-6394a90a1a9a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nimodipine
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler BIONPHARMA INC.
Application ANDA076740
Marketing category ANDA
Marketing start 2017-11-21
Substance NIMODIPINE
Active strength 30 mg/1
Pharmacologic classes Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076740-001 NIMODIPINE NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076740-001 AB
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 · 42 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 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Nimodipine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NIMODIPINE 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 57WA9QZ5WH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198037 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 69452-209-13 Nimodipine 10 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 10 4 69452-209-13 Nimodipine 3 in 1 CARTON CAPSULE, LIQUID FILLED 3 4 69452-209-20 Nimodipine 10 in 1 CARTON CAPSULE, LIQUID FILLED 10 4 69452-209-20 Nimodipine 10 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-209 NIMODIPINE CAPSULE, LIQUID FILLED [BIONPHARMA INC.] 3 Current NDC, Legacy NDC, 4 package rows 20231228_e65d5108-22a2-4d87-a78d-15606f3cc9e2.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 69452-209-13 69452020913 3 BLISTER PACK in 1 CARTON (69452-209-13) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 3 blister pack 2017-11-21 0000-00-00 No No Current 69452-209-20 69452020920 10 BLISTER PACK in 1 CARTON (69452-209-20) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 10 blister pack 2017-11-21 0000-00-00 No No Current