Home NDC 60758-773 KETOROLAC TROMETHAMINE
Product NDC 60758-773
11-digit product format 607580773
Labeler code 60758
Product ID 60758-773_92d01843-b71d-45d6-b752-2c935c6740a2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ketorolac Tromethamine
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Pacific Pharma, Inc.
Application NDA021528
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2013-11-21
Substance KETOROLAC TROMETHAMINE
Active strength 4 mg/mL
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
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 N021528-001 ACULAR LS KETOROLAC TROMETHAMINE 0.4% SOLUTION/DROPS / OPHTHALMIC RLD 2003-05-30
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021528-001 8008338 2027-05-24 U-1181 Drug substance, Drug product 2011-09-23 N021528-001 8008338*PED 2027-11-24 Pediatric extension
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 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021528-001 ACULAR LS 0.4% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 2003-05-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 11 · 432 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021528-001 8008338 2027-05-24 U-1181 Drug substance, Drug product 2011-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021528-001 8008338*PED 2027-11-24 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021528-001 8008338 2027-05-24 U-1181 Drug substance, Drug product 2011-09-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021528-001 8008338*PED 2027-11-24 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021528-001 8008338 2027-05-24 U-1181 Drug substance, Drug product 2011-09-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021528-001 8008338*PED 2027-11-24 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021528-001 8008338 2027-05-24 U-1181 Drug substance, Drug product 2011-09-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021528-001 8008338*PED 2027-11-24 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021528-001 8008338 2027-05-24 U-1181 Drug substance, Drug product 2011-09-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021528-001 8008338*PED 2027-11-24 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021528-001 8207215 2024-05-28 U-1251 2012-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021528-001 8377982 2024-05-28 U-1363 2013-03-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021528-001 8541463 2024-05-28 U-1441 2013-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021528-001 8648107 2024-05-28 Drug product 2014-03-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021528-001 8906950 2024-05-28 U-1626 2015-01-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021528-001 8946281 2024-05-28 U-1662 2015-03-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021528-001 9216167 2024-05-28 U-1800 2016-01-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021528-001 8207215*PED 2024-11-28 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021528-001 8377982*PED 2024-11-28 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021528-001 8541463*PED 2024-11-28 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021528-001 8008338 2027-05-24 U-1181 Drug substance, Drug product 2011-09-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021528-001 8008338*PED 2027-11-24 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021528-001 8207215 2024-05-28 U-1251 2012-07-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021528-001 8377982 2024-05-28 U-1363 2013-03-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021528-001 8541463 2024-05-28 U-1441 2013-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021528-001 8648107 2024-05-28 Drug product 2014-03-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021528-001 8906950 2024-05-28 U-1626 2015-01-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021528-001 8946281 2024-05-28 U-1662 2015-03-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021528-001 9216167 2024-05-28 U-1800 2016-01-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021528-001 8207215*PED 2024-11-28 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021528-001 8377982*PED 2024-11-28 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021528-001 8541463*PED 2024-11-28 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021528-001 8008338 2027-05-24 U-1181 Drug substance, Drug product 2011-09-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021528-001 8008338*PED 2027-11-24 Pediatric extension 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021528-001 8207215 2024-05-28 U-1251 2012-07-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021528-001 8377982 2024-05-28 U-1363 2013-03-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021528-001 8541463 2024-05-28 U-1441 2013-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021528-001 8648107 2024-05-28 Drug product 2014-03-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021528-001 8906950 2024-05-28 U-1626 2015-01-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021528-001 8946281 2024-05-28 U-1662 2015-03-04 5bbf6a4d5a75…
Additional Listing Data#
Finished product Yes
Brand name base KETOROLAC TROMETHAMINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength KETOROLAC TROMETHAMINE 4 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4EVE5946BQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 860103 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 60758-773-05 KETOROLAC TROMETHAMINE 1 in 1 CARTON SOLUTION/ DROPS 1 8 60758-773-05 KETOROLAC TROMETHAMINE 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Ketorolac Tromethamine ACTIVE INGREDIENT 4EVE5946BQ KETOROLAC TROMETHAMINE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 1 Ketorolac Tromethamine ACTIVE INGREDIENT 4EVE5946BQ KETOROLAC TROMETHAMINE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 1 Ketorolac ACTIVE MOIETY YZI5105V0L KETOROLAC TROMETHAMINE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 1 Ketorolac ACTIVE MOIETY YZI5105V0L KETOROLAC TROMETHAMINE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 1 benzalkonium chloride INACTIVE INGREDIENT F5UM2KM3W7 KETOROLAC TROMETHAMINE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 1 benzalkonium chloride INACTIVE INGREDIENT F5UM2KM3W7 KETOROLAC TROMETHAMINE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 1 edetate disodium INACTIVE INGREDIENT 7FLD91C86K KETOROLAC TROMETHAMINE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 1 edetate disodium INACTIVE INGREDIENT 7FLD91C86K KETOROLAC TROMETHAMINE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 1 hydrochloric acid INACTIVE INGREDIENT QTT17582CB KETOROLAC TROMETHAMINE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 1 hydrochloric acid INACTIVE INGREDIENT QTT17582CB KETOROLAC TROMETHAMINE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 1 octoxynol-40 INACTIVE INGREDIENT 9T1C662FKS KETOROLAC TROMETHAMINE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 1 octoxynol-40 INACTIVE INGREDIENT 9T1C662FKS KETOROLAC TROMETHAMINE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 1 sodium chloride INACTIVE INGREDIENT 451W47IQ8X KETOROLAC TROMETHAMINE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 1 sodium chloride INACTIVE INGREDIENT 451W47IQ8X KETOROLAC TROMETHAMINE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 1 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I KETOROLAC TROMETHAMINE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 1 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I KETOROLAC TROMETHAMINE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R KETOROLAC TROMETHAMINE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R KETOROLAC TROMETHAMINE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60758-773 KETOROLAC TROMETHAMINE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20240702_8432a1c5-15e5-4e3d-8e2d-49646e6b7eda.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 · 3 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 60758-773-05 60758077305 1 BOTTLE, DROPPER in 1 CARTON (60758-773-05) / 5 mL in 1 BOTTLE, DROPPER 2013-11-21 0000-00-00 No No Current