Home NDC 83301-0080 Bumetanide
Product NDC 83301-0080
11-digit product format 833010080
Labeler code 83301
Product ID 83301-0080_4c241a3e-649b-4414-e063-6294a90a3a32
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bumetanide
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Mullan Pharmaceutical Inc.
Application ANDA219116
Marketing category ANDA
Marketing start 2025-08-12
Substance BUMETANIDE
Active strength .25 mg/mL
Pharmacologic classes Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219116-001 BUMETANIDE BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219116-001 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.
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 A219116-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219116-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219116-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219116-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219116-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A219116-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A219116-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A219116-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A219116-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-19 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A219116-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A219116-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-19 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219116-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-19 a50c72e98297…
Observed Orange Book normalized TE history# 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 Bumetanide
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUMETANIDE .25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0Y2S3XUQ5H Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 282486 Internal RxNorm lookup 1727569 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 83301-0080-1 Bumetanide 4 mL in 1 VIAL, SINGLE-DOSE INJECTION 4 3 83301-0080-2 Bumetanide 10 in 1 CARTON INJECTION 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83301-0080 BUMETANIDE INJECTION [MULLAN PHARMACEUTICAL INC.] 1 Current NDC, 2 package rows 20250425_b7cd724b-817b-4b45-8133-1ebf505867e7.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 Units Marketing start Sample Exclude flag Status 83301-0080-1 83301008001 4 mL in 1 VIAL, SINGLE-DOSE 4 ml Historical 83301-0080-2 83301008002 10 VIAL, SINGLE-DOSE in 1 CARTON (83301-0080-2) / 4 mL in 1 VIAL, SINGLE-DOSE (83301-0080-1) 2025-08-12 No No Current