FDA.reportPublic FDA data

Nimodipine

Product NDC
69452-209
11-digit product format
694520209
Labeler code
69452
Product ID
69452-209_452704d5-dbeb-5833-e063-6394a90a1a9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nimodipine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
BIONPHARMA INC.
Application
ANDA076740
Marketing category
ANDA
Marketing start
2017-11-21
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
2026-12-31
Current FDA listing
Yes

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
ndc (product): 69452-209

Additional Listing Data#

Finished product
Yes
Brand name base
Nimodipine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIMODIPINE30 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
57WA9QZ5WHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198037Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e65d5108-22a2-4d87-a78d-15606f3cc9e2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1c652b1c-164c-48c3-ae98-4d96fe16a1a2Product name120251114
d941181f-1f0c-c11b-5ab9-a359f0ca2e83Product name220250304
4b413d86-9489-373a-0c33-320b9817a388Product name320150731

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-209-13Nimodipine10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED104
69452-209-13Nimodipine3 in 1 CARTONCAPSULE, LIQUID FILLED34
69452-209-20Nimodipine10 in 1 CARTONCAPSULE, LIQUID FILLED104
69452-209-20Nimodipine10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-209-13EA - Each69452-20972c304a4-a0d4-423f-8353-a76425570c4f12018-01-12
69452-209-20EA - Each69452-209421e8b06-92eb-4ea7-958c-efb144186bb212018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-209NIMODIPINE CAPSULE, LIQUID FILLED [BIONPHARMA INC.]3Current NDC, Legacy NDC, 4 package rows20231228_e65d5108-22a2-4d87-a78d-15606f3cc9e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198037niMODipine 30 MG Oral CapsulePSNe65d5108-22a2-4d87-a78d-15606f3cc9e24
198037nimodipine 30 MG Oral CapsuleSCDe65d5108-22a2-4d87-a78d-15606f3cc9e24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-209-13694520209133 BLISTER PACK in 1 CARTON (69452-209-13) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK3 blister pack2017-11-210000-00-00NoNoCurrent
69452-209-206945202092010 BLISTER PACK in 1 CARTON (69452-209-20) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK10 blister pack2017-11-210000-00-00NoNoCurrent