Home NDC 23155-108-00 Nimodipine
Product NDC 23155-108
Requested package NDC 23155-108-00
11-digit product format 231550108
Labeler code 23155
Product ID 23155-108_bedeb898-d41b-4aed-a63f-616c236b6d8d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nimodipine
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Heritage Pharmaceuticals Inc.
Application ANDA076740
Marketing category ANDA
Marketing start 2008-03-21
Marketing end 0000-00-00
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 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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.
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 2026-08-01 22:54:32 2026-06 A076740-001 NIMODIPINE 30MG CAPSULE / ORAL AB RS 2008-01-17 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A076740-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Nimodipine NIMODIPINE BIONPHARMA INC. e65d5108-22a2-4d87-a78d-15606f3cc9e2 2025-12-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 076740 application number: ANDA076740
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NIMODIPINE ACTIVE INGREDIENT 57WA9QZ5WH NIMODIPINE CAPSULE, LIQUID FILLED [HERITAGE] 12 NIMODIPINE ACTIVE MOIETY 57WA9QZ5WH NIMODIPINE CAPSULE, LIQUID FILLED [HERITAGE] 12 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 NIMODIPINE CAPSULE, LIQUID FILLED [HERITAGE] 12 GELATIN INACTIVE INGREDIENT 2G86QN327L NIMODIPINE CAPSULE, LIQUID FILLED [HERITAGE] 12 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NIMODIPINE CAPSULE, LIQUID FILLED [HERITAGE] 12 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO NIMODIPINE CAPSULE, LIQUID FILLED [HERITAGE] 12 MANNITOL INACTIVE INGREDIENT 3OWL53L36A NIMODIPINE CAPSULE, LIQUID FILLED [HERITAGE] 12 PEPPERMINT OIL INACTIVE INGREDIENT AV092KU4JH NIMODIPINE CAPSULE, LIQUID FILLED [HERITAGE] 12 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A NIMODIPINE CAPSULE, LIQUID FILLED [HERITAGE] 12 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 NIMODIPINE CAPSULE, LIQUID FILLED [HERITAGE] 12 SORBITOL INACTIVE INGREDIENT 506T60A25R NIMODIPINE CAPSULE, LIQUID FILLED [HERITAGE] 12 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NIMODIPINE CAPSULE, LIQUID FILLED [HERITAGE] 12
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 23155-108-00 23155010800 10 BLISTER PACK in 1 CARTON (23155-108-00) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (23155-108-11) 10 blister pack 2008-03-21 0000-00-00 No No Current