Home NDC 31722-039 Nimodipine
Product NDC 31722-039
11-digit product format 317220039
Labeler code 31722
Product ID 31722-039_1dad1404-27c7-4545-e063-6294a90a0cdb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nimodipine
Dosage form SOLUTION
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA216937
Marketing category ANDA
Marketing start 2024-07-09
Substance NIMODIPINE
Active strength 60 mg/20mL
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216937-001 NIMODIPINE NIMODIPINE 3MG/ML SOLUTION / ORAL RS 2024-07-09
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 2026-02-19 14:30 UTC 2026-02 A216937-001 NIMODIPINE 3MG/ML SOLUTION / ORAL RS 2024-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216937-001 NIMODIPINE 3MG/ML SOLUTION / ORAL RS 2024-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216937-001 NIMODIPINE 3MG/ML SOLUTION / ORAL RS 2024-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216937-001 NIMODIPINE 3MG/ML SOLUTION / ORAL RS 2024-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216937-001 NIMODIPINE 3MG/ML SOLUTION / ORAL RS 2024-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216937-001 NIMODIPINE 3MG/ML SOLUTION / ORAL RS 2024-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216937-001 NIMODIPINE 3MG/ML SOLUTION / ORAL RS 2024-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216937-001 NIMODIPINE 3MG/ML SOLUTION / ORAL 2024-07-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216937-001 NIMODIPINE 3MG/ML SOLUTION / ORAL 2024-07-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216937-001 NIMODIPINE 3MG/ML SOLUTION / ORAL 2024-07-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216937-001 NIMODIPINE 3MG/ML SOLUTION / ORAL 2024-07-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216937-001 NIMODIPINE 3MG/ML SOLUTION / ORAL 2024-07-09 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216937-001 NIMODIPINE 3MG/ML SOLUTION / ORAL RS 2024-07-09 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Nimodipine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NIMODIPINE 60 mg/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 57WA9QZ5WH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1423767 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 31722-039-47 Nimodipine 473 mL in 1 BOTTLE SOLUTION 473 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-039 NIMODIPINE (NIMODIPINE) SOLUTION [CAMBER PHARMACEUTICALS, INC.] 1 Current NDC, 1 package rows 20240721_f829de8b-fabd-4aec-ac8d-c9aaef7be55b.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 31722-039-47 31722003947 473 mL in 1 BOTTLE (31722-039-47) 473 ml 2024-07-09 No No Current