Home NDC 70748-323 BUMETANIDE
Product NDC 70748-323
11-digit product format 707480323
Labeler code 70748
Product ID 70748-323_45b58710-b405-44fe-8734-aadc2731bb15
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 2026-10-15 13:18:30 2026-09 A217153-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-17 c2088c7a36db…2026-09-14 22:38:34 2026-08 A217153-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217153-001 BUMETANIDE 0.25MG/ML INJECTABLE / INJECTION AP 2024-09-17 caaa826d4ba7…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# 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
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
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