FDA.reportPublic FDA data

Nimodipine

Product NDC
0904-6566
11-digit product format
009046566
Labeler code
0904
Product ID
0904-6566_44058f6a-cccf-4503-b197-864b1d4964db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nimodipine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA090103
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
2019-12-16
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

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0904-6566DDiscontinued by firm2026-07-31
excluded packagepackage0904-65660904-6566-04DDiscontinued by firm2026-07-31
excluded packagepackage0904-65660904-6566-61DDiscontinued 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
A090103-001NIMODIPINENIMODIPINE30MGCAPSULE / ORALAB2014-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090103-001AB

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 22:54:322026-06A090103-001NIMODIPINE30MGCAPSULE / ORALAB2014-04-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090103-001AB1a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6566-04EA - Each0904-6566d5527b9b-20ff-4c7d-93c5-389f2028b8d112016-05-16
0904-6566-61EA - Each0904-6566a593f8c1-d856-440e-9cc5-4fb9ca9f0dc412016-05-16