Home NDC 84549-605-25 verapamil hydrochloride
Product NDC 84549-605
Requested package NDC 84549-605-25
11-digit product format 845490605
Labeler code 84549
Product ID 84549-605_463d9778-2a56-83f4-e063-6394a90a58a9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name verapamil hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler ProPharma Distribution
Application ANDA214653
Marketing category ANDA
Marketing start 2022-06-16
Substance VERAPAMIL HYDROCHLORIDE
Active strength 2.5 mg/mL
Pharmacologic classes Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
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 43 .
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 A214653-001 VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214653-001 AP
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 2026-09-14 22:38:34 2026-08 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214653-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2022-06-15 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base verapamil hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VERAPAMIL HYDROCHLORIDE 2.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V3888OEY5R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1665057 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 84549-605-25 verapamil hydrochloride 2 mL in 1 VIAL INJECTION, SOLUTION 2 3
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 · 3 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 84549-605-25 84549060525 2 mL in 1 VIAL (84549-605-25) 2 ml 2025-08-27 No No Current