Home NDC 51754-0204 Verapamil Hydrochloride
Product NDC 51754-0204
11-digit product format 517540204
Labeler code 51754
Product ID 51754-0204_f1a97533-a1b0-4b0e-b4c2-76d5bee9b4e2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Verapamil Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler EXELA PHARMA SCIENCES, LLC
Application NDA018925
Marketing category NDA
Marketing start 2017-02-01
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 1 .
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 N018925-001 VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 1984-03-30 N018925-002 VERAPAMIL HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-04-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018925-001 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.
Product history page 1 of 3 · 82 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 2026-02-19 14:30 UTC 2026-02 N018925-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 1984-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018925-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-04-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018925-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 1984-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018925-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-04-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018925-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 1984-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018925-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-04-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018925-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 1984-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018925-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-04-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018925-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 1984-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018925-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-04-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018925-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 1984-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018925-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-04-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018925-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 1984-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018925-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-04-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018925-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 1984-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018925-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-04-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018925-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 1984-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018925-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-04-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018925-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 1984-03-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018925-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-04-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018925-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 1984-03-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018925-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-04-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018925-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 1984-03-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018925-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-04-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018925-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 1984-03-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018925-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-04-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018925-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 1984-03-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N018925-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-04-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018925-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 1984-03-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018925-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-04-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018925-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 1984-03-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N018925-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-04-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018925-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 1984-03-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N018925-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-04-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018925-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 1984-03-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N018925-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 2018-04-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018925-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 1984-03-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N018925-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-04-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018925-001 VERAPAMIL HYDROCHLORIDE 5MG/2ML (2.5MG/ML) SOLUTION / INTRAVENOUS AP 1984-03-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N018925-002 VERAPAMIL HYDROCHLORIDE 10MG/4ML (2.5MG/ML) SOLUTION / INTRAVENOUS 2018-04-05 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 47 observed states.
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 Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51754-0204 VERAPAMIL HYDROCHLORIDE INJECTION [EXELA PHARMA SCIENCES, LLC] 1 Current NDC, Legacy NDC 20170201_3318e357-0660-44f4-8170-91a51bd762fb.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VERAPAMIL HCI VERAPAMIL HCI HF Acquisition Co LLC, DBA HealthFirst 9a4f12ec-fe1c-a1b9-e053-2a95a90ac8e4 2024-02-26 Warnings, Adverse reactions Exact identifier application applno (NDA): 018925 application number: NDA018925 Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE Medical Purchasing Solutions, LLC 6685248d-908e-cd07-e053-2a91aa0ac718 2023-05-30 Warnings, Adverse reactions Exact identifier application applno (NDA): 018925 application number: NDA018925 Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE EXELA PHARMA SCIENCES, LLC eff5e83b-f819-4a5b-9746-12bce328d7a7 2017-02-21 Warnings, Adverse reactions Exact identifier application applno (NDA): 018925 application number: NDA018925 Verapamil Hydrochloride VERAPAMIL HYDROCHLORIDE EXELA PHARMA SCIENCES, LLC 3318e357-0660-44f4-8170-91a51bd762fb 2017-01-23 Warnings, Adverse reactions Exact identifier application applno (NDA): 018925 application number: NDA018925 ndc (product): 51754-0204
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 51754-0204-2 51754020402 5 VIAL in 1 CARTON (51754-0204-2) / 2 mL in 1 VIAL 5 vial 2017-02-01 0000-00-00 No No Current 51754-0204-4 51754020404 25 VIAL in 1 CARTON (51754-0204-4) / 2 mL in 1 VIAL 25 vial 2017-02-01 0000-00-00 No No Current