Home NDC 83854-007 Bumetanide
Product NDC 83854-007
11-digit product format 838540007
Labeler code 83854
Product ID 83854-007_4bdda2c6-2da0-c887-e063-6294a90a4119
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bumetanide
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Anthea Pharma Private Limited
Application ANDA220427
Marketing category ANDA
Marketing start 2026-02-27
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 1 .
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 A220427-001 BUMETANIDE BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2026-02-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220427-001 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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220427-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2026-02-26 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220427-001 AP 1 a50c72e98297…
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 83854-007-01 Bumetanide 4 mL in 1 VIAL INJECTION, SOLUTION 4 3 83854-007-10 Bumetanide 10 in 1 CARTON INJECTION, SOLUTION 10 3
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 · 1 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 83854-007-01 83854000701 4 mL in 1 VIAL 4 ml Historical 83854-007-10 83854000710 10 VIAL in 1 CARTON (83854-007-10) / 4 mL in 1 VIAL (83854-007-01) 10 vial 2026-02-27 No No Current