Home NDC 70518-4757 Gentamicin
Product NDC 70518-4757
11-digit product format 705184757
Labeler code 70518
Product ID 70518-4757_5bfe7519-4b6c-1897-e063-6294a90a4e1f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gentamicin
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler REMEDYREPACK INC.
Application ANDA215237
Marketing category ANDA
Marketing start 2026-09-17
Substance GENTAMICIN SULFATE
Active strength 40 mg/mL
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
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 A215237-001 GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215237-001 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 A215237-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215237-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215237-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215237-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215237-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215237-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215237-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215237-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215237-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215237-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215237-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215237-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215237-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215237-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215237-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215237-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215237-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215237-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215237-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 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 Gentamicin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GENTAMICIN SULFATE 40 mg/mL
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70518-4757-0 70518475700 25 VIAL, MULTI-DOSE in 1 CARTON (70518-4757-0) / 2 mL in 1 VIAL, MULTI-DOSE (70518-4757-1) 2026-09-17 No No Current