Home NDC 0009-3794-01 Corvert
Product NDC 0009-3794
Requested package NDC 0009-3794-01
11-digit product format 000093794
Labeler code 0009
Product ID 0009-3794_1cc20301-7541-43e5-8034-8306028c50a4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ibutilide fumarate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Pharmacia & Upjohn Company LLC
Application NDA020491
Marketing category NDA
Marketing start 1995-12-28
Substance IBUTILIDE FUMARATE
Active strength .1 mg/mL
Pharmacologic classes Antiarrhythmic [EPC]
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 N020491-001 CORVERT IBUTILIDE FUMARATE 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020491-001 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 2 · 43 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 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020491-001 CORVERT 0.1MG/ML INJECTABLE / INJECTION AP RLD, RS 1995-12-28 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 Corvert
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUTILIDE FUMARATE .1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9L5X4M5L6I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 979120 Internal RxNorm lookup 979122 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 0009-3794-01 Corvert 1 in 1 CARTON INJECTION, SOLUTION 1 11 0009-3794-01 Corvert 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 11 0009-3794-22 Corvert 1 in 1 CARTON INJECTION, SOLUTION 1 9 0009-3794-22 Corvert 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUTILIDE FUMARATE ACTIVE INGREDIENT 9L5X4M5L6I CORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY] 4 IBUTILIDE ACTIVE MOIETY 2436VX1U9B CORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY] 4 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB CORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY] 4 SODIUM ACETATE INACTIVE INGREDIENT 4550K0SC9B CORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY] 4 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X CORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY] 4 WATER INACTIVE INGREDIENT 059QF0KO0R CORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY] 4 ibutilide fumarate ACTIVE INGREDIENT 9L5X4M5L6I CORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY] 2 ibutilide ACTIVE MOIETY 2436VX1U9B CORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY] 2 hydrochloric acid INACTIVE INGREDIENT QTT17582CB CORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY] 2 sodium acetate INACTIVE INGREDIENT 4550K0SC9B CORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY] 2 sodium chloride INACTIVE INGREDIENT 451W47IQ8X CORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY] 2 Water INACTIVE INGREDIENT 059QF0KO0R CORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0009-3794 CORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC] 11 Current NDC, Legacy NDC, 2 package rows 20240126_b7d717ed-022d-4459-b5e6-098c2a8b7427.zip 0009-3794 CORVERT (IBUTILIDE FUMARATE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC] 9 Current NDC, Legacy NDC, 2 package rows 20240126_2428969a-7431-4e94-9503-ad5c680e2ea4.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0009-3794-01 00009379401 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-3794-01) / 10 mL in 1 VIAL, SINGLE-DOSE 1995-12-28 0000-00-00 No No Current