Home NDC 70748-323 BUMETANIDE
Product NDC 70748-323
11-digit product format 707480323
Labeler code 70748
Product ID 70748-323_39d376d9-2fab-40d3-8592-668c5083a0c9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bumetanide
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA217153
Marketing category ANDA
Marketing start 2024-11-11
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 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217153-001 BUMETANIDE BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217153-001 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 2026-02-19 14:30 UTC 2026-02 A217153-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217153-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217153-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217153-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217153-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217153-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217153-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-17 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217153-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217153-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-17 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217153-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-17 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base BUMETANIDE
Listing expiration 2026-12-31 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 70748-323-10 BUMETANIDE 4 mL in 1 VIAL INJECTION 4 6 70748-323-10 BUMETANIDE 10 in 1 CARTON INJECTION 10 6 70748-323-11 BUMETANIDE 10 in 1 CARTON INJECTION 10 6 70748-323-11 BUMETANIDE 10 mL in 1 VIAL INJECTION 10 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70748-323 BUMETANIDE INJECTION [LUPIN PHARMACEUTICALS, INC.] 5 Current NDC, 4 package rows 20250418_2c71a17e-ed76-4545-b23e-9f4997b13c2f.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 · 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 70748-323-10 70748032310 10 VIAL in 1 CARTON (70748-323-10) / 4 mL in 1 VIAL 10 vial 2024-11-11 No No Current 70748-323-11 70748032311 10 VIAL in 1 CARTON (70748-323-11) / 10 mL in 1 VIAL 10 vial 2024-11-11 No No Current