Home NDC 72205-058-05 Bumetanide
Product NDC 72205-058
Requested package NDC 72205-058-05
11-digit product format 722050058
Labeler code 72205
Product ID 72205-058_cddd33fb-25b0-49ca-ab32-7c79a9b3a384
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bumetanide
Dosage form TABLET
Route ORAL
Labeler Novadoz Pharmaceuticals LLC
Application ANDA215362
Marketing category ANDA
Marketing start 2026-02-05
Substance BUMETANIDE
Active strength 2 mg/1
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215362-001 BUMETANIDE BUMETANIDE 0.5MG TABLET / ORAL AB 2026-02-05 A215362-002 BUMETANIDE BUMETANIDE 1MG TABLET / ORAL AB 2026-02-05 A215362-003 BUMETANIDE BUMETANIDE 2MG TABLET / ORAL AB 2026-02-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 A215362-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2026-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215362-002 BUMETANIDE 1MG TABLET / ORAL AB 2026-02-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215362-003 BUMETANIDE 2MG TABLET / ORAL AB 2026-02-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215362-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2026-02-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215362-002 BUMETANIDE 1MG TABLET / ORAL AB 2026-02-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215362-003 BUMETANIDE 2MG TABLET / ORAL AB 2026-02-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215362-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2026-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215362-002 BUMETANIDE 1MG TABLET / ORAL AB 2026-02-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215362-003 BUMETANIDE 2MG TABLET / ORAL AB 2026-02-05 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215362-001 BUMETANIDE 0.5MG TABLET / ORAL AB 2026-02-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215362-002 BUMETANIDE 1MG TABLET / ORAL AB 2026-02-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215362-003 BUMETANIDE 2MG TABLET / ORAL AB 2026-02-05 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 2 mg/1
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197417 Internal RxNorm lookup 197418 Internal RxNorm lookup 197419 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 72205-058-05 Bumetanide 500 in 1 BOTTLE TABLET 500 1 72205-058-91 Bumetanide 100 in 1 BOTTLE TABLET 100 1
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 72205-058-05 72205005805 500 TABLET in 1 BOTTLE (72205-058-05) 500 tablet 2026-02-10 No No Current