FDA.reportPublic FDA data

Nimodipine

Product NDC
57664-135
11-digit product format
576640135
Labeler code
57664
Product ID
57664-135_b9f244e4-bf34-4f84-9507-4a56e21b8d8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nimodipine
Dosage form
CAPSULE
Route
ORAL
Labeler
Caraco Pharmaceutical Laboratories, Ltd.
Application
ANDA077067
Marketing category
ANDA
Marketing start
2007-06-28
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
2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57664-135DDiscontinued by firm2026-07-31
excluded packagepackage57664-13557664-135-64DDiscontinued by firm2026-07-31
excluded packagepackage57664-13557664-135-65DDiscontinued 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
A077067-001NIMODIPINENIMODIPINE30MGCAPSULE / ORAL2007-04-17

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 22:54:322026-06A077067-001NIMODIPINE30MGCAPSULE / ORAL2007-04-17a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-135-60EA - Each57664-135092f7315-325e-4ceb-b205-121f5c12234612013-02-13
57664-135-64EA - Each57664-1353394bc86-5ff8-49ac-aa22-1a11618afcc212012-07-24
57664-135-65EA - Each57664-1350f8a9c75-55f1-49c4-bc79-c4f5d48a18b412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NIMODIPINEACTIVE INGREDIENT57WA9QZ5WHNIMODIPINE (NIMODIPINE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]5
NIMODIPINEACTIVE MOIETY57WA9QZ5WHNIMODIPINE (NIMODIPINE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MNIMODIPINE (NIMODIPINE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]5
AMMONIAINACTIVE INGREDIENT5138Q19F1XNIMODIPINE (NIMODIPINE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]5
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3NIMODIPINE (NIMODIPINE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNIMODIPINE (NIMODIPINE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NIMODIPINE (NIMODIPINE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]5
GELATININACTIVE INGREDIENT2G86QN327LNIMODIPINE (NIMODIPINE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNIMODIPINE (NIMODIPINE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]5
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302NIMODIPINE (NIMODIPINE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]5
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UNIMODIPINE (NIMODIPINE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]5
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JHNIMODIPINE (NIMODIPINE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIMODIPINE (NIMODIPINE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIMODIPINE (NIMODIPINE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]5
SHELLACINACTIVE INGREDIENT46N107B71ONIMODIPINE (NIMODIPINE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNIMODIPINE (NIMODIPINE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]5
WATERINACTIVE INGREDIENT059QF0KO0RNIMODIPINE (NIMODIPINE ) CAPSULE [CARACO PHARMACEUTICAL LABORATORIES, LTD.]5