Home NDC 70121-1586-3 Verapamil Hydrochloride
Product NDC 70121-1586
Requested package NDC 70121-1586-3
11-digit product format 701211586
Labeler code 70121
Product ID 70121-1586_87cb3647-64f7-4552-8d42-c4090492991a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Verapamil Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Amneal Pharmaceuticals LLC
Application ANDA210994
Marketing category ANDA
Marketing start 2018-07-17
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210994-001 VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-07-13 A210994-002 VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-07-13
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.
Product history page 1 of 3 · 88 observed 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 2026-10-15 13:18:30 2026-09 A210994-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-07-13 c2088c7a36db…2026-10-15 13:18:30 2026-09 A210994-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-07-13 c2088c7a36db…2026-09-14 22:38:34 2026-08 A210994-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-07-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210994-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-07-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210994-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-07-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210994-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-07-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210994-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210994-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210994-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210994-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210994-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210994-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210994-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210994-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210994-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210994-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210994-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210994-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210994-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210994-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210994-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210994-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210994-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210994-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210994-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210994-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210994-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210994-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210994-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210994-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210994-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210994-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210994-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210994-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210994-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210994-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210994-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210994-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210994-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210994-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-07-13 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
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 2027-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1665057 Internal RxNorm lookup 1665061 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 70121-1586-1 Verapamil Hydrochloride 4 mL in 1 VIAL INJECTION, SOLUTION 4 7 70121-1586-3 Verapamil Hydrochloride 5 in 1 CARTON INJECTION, SOLUTION 5 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70121-1586 VERAPAMIL HYDROCHLORIDE INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS LLC] 7 Current NDC, Legacy NDC, 2 package rows 20240711_9055ed6b-f466-4f38-a9d9-f22e9ac97ad4.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 Marketing end Sample Exclude flag Status 70121-1586-3 70121158603 5 VIAL in 1 CARTON (70121-1586-3) / 4 mL in 1 VIAL (70121-1586-1) 5 vial 2018-07-17 0000-00-00 No No Current