Home NDC 17478-284-35 Gentak
Product NDC 17478-284
Requested package NDC 17478-284-35
11-digit product format 174780284
Labeler code 17478
Product ID 17478-284_50c5ed21-5a73-40cb-aa7a-0e1ba3b7bbb4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gentamicin Sulfate
Dosage form OINTMENT
Route OPHTHALMIC
Labeler Akorn
Application ANDA064093
Marketing category ANDA
Marketing start 2006-05-08
Marketing end 0000-00-00
Substance GENTAMICIN SULFATE
Active strength 3 mg/g
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 A064093-001 GENTAMICIN SULFATE GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31
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 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC 1995-08-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A064093-001 GENTAMICIN SULFATE EQ 0.3% BASE OINTMENT / OPHTHALMIC AT RS 1995-08-31 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17478-284-35 Gentak 1 in 1 CARTON OINTMENT 1 6 17478-284-35 Gentak 3.5 g in 1 TUBE OINTMENT 3.5 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GENTAMICIN SULFATE ACTIVE INGREDIENT 8X7386QRLV GENTAK (GENTAMICIN SULFATE) OINTMENT [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 5000 GENTAMICIN ACTIVE MOIETY T6Z9V48IKG GENTAK (GENTAMICIN SULFATE) OINTMENT [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 5000 GENTAMICIN SULFATE INACTIVE INGREDIENT 8X7386QRLV GENTAK (GENTAMICIN SULFATE) OINTMENT [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 5000 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T GENTAK (GENTAMICIN SULFATE) OINTMENT [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 5000 Mineral Oil INACTIVE INGREDIENT T5L8T28FGP GENTAK (GENTAMICIN SULFATE) OINTMENT [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 5000 Petrolatum INACTIVE INGREDIENT 4T6H12BN9U GENTAK (GENTAMICIN SULFATE) OINTMENT [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 5000 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH GENTAK (GENTAMICIN SULFATE) OINTMENT [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 5000 Gentamicin Sulfate ACTIVE INGREDIENT 8X7386QRLV GENTAK (GENTAMICIN SULFATE) OINTMENT [AKORN, INC.] 1 Gentamicin Sulfate ACTIVE INGREDIENT 8X7386QRLV GENTAK (GENTAMICIN SULFATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.] 1 Gentamicin ACTIVE MOIETY T6Z9V48IKG GENTAK (GENTAMICIN SULFATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.] 1 Gentamicin ACTIVE MOIETY T6Z9V48IKG GENTAK (GENTAMICIN SULFATE) OINTMENT [AKORN, INC.] 1 Gentamicin Sulfate INACTIVE INGREDIENT 8X7386QRLV GENTAK (GENTAMICIN SULFATE) OINTMENT [AKORN, INC.] 1 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T GENTAK (GENTAMICIN SULFATE) OINTMENT [AKORN, INC.] 1 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T GENTAK (GENTAMICIN SULFATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.] 1 Mineral Oil INACTIVE INGREDIENT T5L8T28FGP GENTAK (GENTAMICIN SULFATE) OINTMENT [AKORN, INC.] 1 Mineral Oil INACTIVE INGREDIENT T5L8T28FGP GENTAK (GENTAMICIN SULFATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.] 1 Petrolatum INACTIVE INGREDIENT 4T6H12BN9U GENTAK (GENTAMICIN SULFATE) OINTMENT [AKORN, INC.] 1 Petrolatum INACTIVE INGREDIENT 4T6H12BN9U GENTAK (GENTAMICIN SULFATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.] 1 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH GENTAK (GENTAMICIN SULFATE) OINTMENT [AKORN, INC.] 1 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH GENTAK (GENTAMICIN SULFATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17478-284 GENTAK (GENTAMICIN SULFATE) OINTMENT [AKORN] 6 Legacy NDC, 2 package rows 20220702_a357d23d-1f10-44ce-a2fa-a6a5e03e7739.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gentak GENTAMICIN SULFATE Proficient Rx LP aebfe247-cdf7-4acb-97b3-6d4341d7c815 2019-11-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 064093 application number: ANDA064093
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 17478-284-35 17478028435 1 TUBE in 1 CARTON (17478-284-35) > 3.5 g in 1 TUBE 1 tube 2006-05-08 0000-00-00 No No Current