Home NDC 0143-9129 Gentamicin
Product NDC 0143-9129
11-digit product format 001439129
Labeler code 0143
Product ID 0143-9129_9908273d-c700-4036-82fe-312f25a8aacd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gentamicin
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA062251
Marketing category ANDA
Marketing start 2022-02-15
Substance GENTAMICIN SULFATE
Active strength 40 mg/mL
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A062251-001 GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 A062251-002 GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
Product history page 1 of 3 · 82 observed 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 A062251-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A062251-002 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062251-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062251-002 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062251-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A062251-002 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062251-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062251-002 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062251-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062251-002 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062251-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062251-002 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062251-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062251-002 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062251-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062251-002 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062251-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062251-002 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062251-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A062251-002 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062251-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062251-002 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062251-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062251-002 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062251-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062251-002 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062251-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A062251-002 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062251-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062251-002 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062251-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A062251-002 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062251-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A062251-002 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062251-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A062251-002 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062251-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A062251-002 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062251-001 GENTAMICIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A062251-002 GENTAMICIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION Approved before 1982 782e0a99824c…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Gentamicin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GENTAMICIN SULFATE 40 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 313996 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 0143-9129-01 Gentamicin 20 mL in 1 VIAL INJECTION, SOLUTION 20 2 0143-9129-10 Gentamicin 10 in 1 CARTON INJECTION, SOLUTION 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9129 GENTAMICIN INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 2 Current NDC, Legacy NDC, 2 package rows 20230908_51fffac8-fb6e-4f7f-b2de-440252781a42.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 Marketing end Sample Exclude flag Status 0143-9129-01 00143912901 20 mL in 1 VIAL 20 ml Historical 0143-9129-10 00143912910 10 VIAL in 1 CARTON (0143-9129-10) / 20 mL in 1 VIAL (0143-9129-01) 10 vial 2022-02-15 0000-00-00 No No Current