Home NDC 68084-912-31 Nimodipine
Product NDC 68084-912
Requested package NDC 68084-912-31
11-digit product format 680840912
Labeler code 68084
Product ID 68084-912_f05be1cf-fc2d-9bf2-e053-2a95a90ac12c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nimodipine
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler American Health Packaging
Application ANDA090103
Marketing category ANDA
Marketing start 2015-02-17
Marketing end 2023-09-30
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 0000-00-00
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 A090103-001 NIMODIPINE NIMODIPINE 30MG CAPSULE / ORAL AB 2014-04-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090103-001 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 A090103-001 NIMODIPINE 30MG CAPSULE / ORAL AB 2014-04-07 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 A090103-001 AB 1 a50c72e98297…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NIMODIPINE ACTIVE INGREDIENT 57WA9QZ5WH NIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 2 NIMODIPINE ACTIVE MOIETY 57WA9QZ5WH NIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 NIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L NIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX NIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 2 PEPPERMINT OIL INACTIVE INGREDIENT AV092KU4JH NIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ NIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 2 WATER INACTIVE INGREDIENT 059QF0KO0R NIMODIPINE CAPSULE, LIQUID FILLED [AMERICAN HEALTH PACKAGING] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68084-912-31 68084091231 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-912-31) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68084-912-33) 100 blister pack 2015-10-30 2023-09-30 No No Current