Home NDC 51754-0203 Verapamil Hydrochloride
Product NDC 51754-0203
11-digit product format 517540203
Labeler code 51754
Product ID 51754-0203_d053ac54-7922-4e79-a5a2-62eb3c2c3f4d
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 2016-04-22
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.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (product): 51754-0203 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
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 · 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 51754-0203-2 Verapamil Hydrochloride 5 in 1 CARTON INJECTION 5 6 51754-0203-2 Verapamil Hydrochloride 2 mL in 1 VIAL INJECTION 2 6 51754-0203-4 Verapamil Hydrochloride 2 mL in 1 VIAL INJECTION 2 6 51754-0203-4 Verapamil Hydrochloride 25 in 1 CARTON INJECTION 25 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51754-0203 VERAPAMIL HYDROCHLORIDE INJECTION [EXELA PHARMA SCIENCES, LLC] 6 Current NDC, Legacy NDC, 4 package rows 20210916_eff5e83b-f819-4a5b-9746-12bce328d7a7.zip
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 51754-0203-2 51754020302 5 VIAL in 1 CARTON (51754-0203-2) / 2 mL in 1 VIAL 5 vial 2016-04-22 0000-00-00 No No Current 51754-0203-4 51754020304 25 VIAL in 1 CARTON (51754-0203-4) / 2 mL in 1 VIAL 25 vial 2016-12-09 0000-00-00 No No Current