Home NDC 0713-0682 Gentamicin Sulfate
Product NDC 0713-0682
11-digit product format 007130682
Labeler code 0713
Product ID 0713-0682_0acd2432-98da-018e-e063-6294a90ad373
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gentamicin Sulfate
Dosage form OINTMENT
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA064054
Marketing category ANDA
Marketing start 2014-11-28
Substance GENTAMICIN SULFATE
Active strength 1 mg/g
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A064054-001 GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A064054-001 AT
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 2 · 41 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 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A064054-001 GENTAMICIN SULFATE EQ 0.1% BASE OINTMENT / TOPICAL AT 1994-04-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Gentamicin Sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GENTAMICIN SULFATE 1 mg/g
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 310465 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 0713-0682-15 Gentamicin Sulfate 1 in 1 CARTON OINTMENT 1 5 0713-0682-15 Gentamicin Sulfate 15 g in 1 TUBE OINTMENT 15 5 0713-0682-31 Gentamicin Sulfate 30 g in 1 TUBE OINTMENT 30 5 0713-0682-31 Gentamicin Sulfate 1 in 1 CARTON OINTMENT 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0682 GENTAMICIN SULFATE OINTMENT [COSETTE PHARMACEUTICALS, INC.] 5 Current NDC, Legacy NDC, 4 package rows 20231123_16474069-510b-0754-9d78-9bc0354f6549.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 · 2 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 0713-0682-15 00713068215 1 TUBE in 1 CARTON (0713-0682-15) / 15 g in 1 TUBE 1 tube 2017-12-21 0000-00-00 No No Current 0713-0682-31 00713068231 1 TUBE in 1 CARTON (0713-0682-31) / 30 g in 1 TUBE 1 tube 2017-12-21 0000-00-00 No No Current