Home NDC 55150-401 Gentamicin
Product NDC 55150-401
11-digit product format 551500401
Labeler code 55150
Product ID 55150-401_ec7eac4d-564f-4f16-b90a-a0c54d403056
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gentamicin
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Eugia US LLC
Application ANDA215236
Marketing category ANDA
Marketing start 2024-01-08
Substance GENTAMICIN SULFATE
Active strength 10 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 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 A215236-001 GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION 2024-01-08
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 A215236-001 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION 2024-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215236-001 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215236-001 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215236-001 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215236-001 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215236-001 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215236-001 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215236-001 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215236-001 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215236-001 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215236-001 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215236-001 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215236-001 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215236-001 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215236-001 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215236-001 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2024-01-08 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215236-001 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION 2024-01-08 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Gentamicin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GENTAMICIN SULFATE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8X7386QRLV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1870676 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 55150-401-01 Gentamicin 2 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 2 2 55150-401-25 Gentamicin 25 in 1 CARTON INJECTION, SOLUTION 25 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55150-401 GENTAMICIN INJECTION, SOLUTION [EUGIA US LLC] 1 Current NDC, 2 package rows 20240110_f8c608b3-50b8-4d5d-9e8a-e92c0d2e3cdc.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 55150-401-01 55150040101 2 mL in 1 VIAL, SINGLE-DOSE 2 ml Historical 55150-401-25 55150040125 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-401-25) / 2 mL in 1 VIAL, SINGLE-DOSE (55150-401-01) 2024-01-08 No No Current