Home NDC 70518-4453 Verapamil Hydrochloride
Product NDC 70518-4453
11-digit product format 705184453
Labeler code 70518
Product ID 70518-4453_5b3633ac-a0b9-0286-e063-6294a90aea11
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name verapamil hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler REMEDYREPACK INC.
Application ANDA213232
Marketing category ANDA
Marketing start 2025-08-21
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 43 .
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 A213232-001 VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 A213232-002 VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2 · 78 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 2026-09-14 22:38:34 2026-08 A213232-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213232-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213232-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213232-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213232-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213232-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213232-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213232-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213232-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213232-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213232-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213232-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213232-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213232-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213232-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213232-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213232-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213232-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213232-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213232-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213232-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213232-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213232-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213232-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213232-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213232-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213232-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213232-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213232-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213232-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213232-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213232-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213232-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213232-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213232-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213232-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213232-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213232-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213232-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A213232-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2020-03-25 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 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
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-4453-0 Verapamil Hydrochloride 25 in 1 CARTON INJECTION, SOLUTION 25 1 70518-4453-1 Verapamil Hydrochloride 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 1
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 · 2 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 70518-4453-0 70518445300 25 VIAL, SINGLE-DOSE in 1 CARTON (70518-4453-0) / 2 mL in 1 VIAL, SINGLE-DOSE (70518-4453-1) 2025-08-21 No No Current 70518-4453-1 70518445301 2 mL in 1 VIAL, SINGLE-DOSE 2 ml Historical