Home NDC 65219-384 Verapamil Hydrochloride
Product NDC 65219-384
11-digit product format 652190384
Labeler code 65219
Product ID 65219-384_f3bdbd6b-0e61-43d3-8016-3edd69bedd38
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Verapamil Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler FRESENIUS KABI USA, LLC
Application ANDA216471
Marketing category ANDA
Marketing start 2024-11-25
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 A216471-001 VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2024-04-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216471-001 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 A216471-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2024-04-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216471-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2024-04-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216471-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2024-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216471-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2024-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216471-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2024-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216471-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2024-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216471-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2024-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216471-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2024-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216471-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2024-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216471-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION 2024-04-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216471-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION 2024-04-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216471-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION 2024-04-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216471-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION 2024-04-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216471-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION 2024-04-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216471-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION 2024-04-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216471-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2024-04-23 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216471-001 VERAPAMIL HYDROCHLORIDE 2.5MG/ML INJECTABLE / INJECTION AP 2024-04-23 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 65219-384-01 Verapamil Hydrochloride 2 mL in 1 VIAL, SINGLE-DOSE INJECTION 2 1 65219-384-02 Verapamil Hydrochloride 25 in 1 CARTON INJECTION 25 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-384 VERAPAMIL HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC ] 1 Current NDC, 2 package rows 20241126_38ca9270-5538-467a-a3e9-c27968f3aafe.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 65219-384-01 65219038401 2 mL in 1 VIAL, SINGLE-DOSE 2 ml Historical 65219-384-02 65219038402 25 VIAL, SINGLE-DOSE in 1 CARTON (65219-384-02) / 2 mL in 1 VIAL, SINGLE-DOSE (65219-384-01) 2024-11-25 No No Current