FDA.reportPublic FDA data

Nimodipine

Product NDC
55154-4184
11-digit product format
551544184
Labeler code
55154
Product ID
55154-4184_f48110e4-29e7-4417-adff-8c7e9e66f341
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nimodipine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Cardinal Health
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55154-4184DDiscontinued by firm2026-07-31
excluded packagepackage55154-418455154-4184-0DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076740-001NIMODIPINENIMODIPINE30MGCAPSULE / ORALABRS2008-01-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A076740-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076740-001NIMODIPINE30MGCAPSULE / ORALABRS2008-01-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076740-001AB1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NimodipineNIMODIPINEBIONPHARMA INC.e65d5108-22a2-4d87-a78d-15606f3cc9e22025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076740
application number: ANDA076740