Home NDC 66267-971 Gentamicin Sulfate
Product NDC 66267-971
11-digit product format 662670971
Labeler code 66267
Product ID 66267-971_1fa7c294-f28b-210b-e063-6294a90aebc9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gentamicin Sulfate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler NuCare Pharmaceuticals, Inc.
Application ANDA064163
Marketing category ANDA
Marketing start 2006-12-13
Substance GENTAMICIN SULFATE
Active strength 3 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A064163-001 GENTAK GENTAMICIN SULFATE EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12
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 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC 2001-10-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A064163-001 GENTAK EQ 0.3% BASE SOLUTION/DROPS / OPHTHALMIC AT 2001-10-12 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 3 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 310467 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 66267-971-05 Gentamicin Sulfate 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 4 66267-971-05 Gentamicin Sulfate 1 in 1 CARTON SOLUTION/ DROPS 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66267-971 GENTAMICIN SULFATE SOLUTION/ DROPS [NUCARE PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20240816_4add8f7b-48f0-6b6a-e054-00144ff88e88.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 Marketing start Marketing end Sample Exclude flag Status 66267-971-05 66267097105 1 BOTTLE, DROPPER in 1 CARTON (66267-971-05) / 5 mL in 1 BOTTLE, DROPPER 2017-03-16 0000-00-00 No No Current