Home NDC 0023-2181 Acular
Product NDC 0023-2181
11-digit product format 000232181
Labeler code 0023
Product ID 0023-2181_fb99e487-9880-4bb9-9271-7bf042a4f0f8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ketorolac Tromethamine
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Allergan, Inc.
Application NDA019700
Marketing category NDA
Marketing start 1992-12-01
Substance KETOROLAC TROMETHAMINE
Active strength 5 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 42 .
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 N019700-001 ACULAR KETOROLAC TROMETHAMINE 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N019700-001 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 · 42 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 2026-08-18 06:07:40 2026-07 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019700-001 ACULAR 0.5% SOLUTION/DROPS / OPHTHALMIC AT RLD, RS 1992-11-09 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Acular
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength KETOROLAC TROMETHAMINE 5 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 860107 Internal RxNorm lookup 860109 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 0023-2181-05 Acular 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 16 0023-2181-05 Acular 1 in 1 CARTON SOLUTION/ DROPS 1 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Ketorolac Tromethamine ACTIVE INGREDIENT 4EVE5946BQ ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.] 6 Ketorolac ACTIVE MOIETY YZI5105V0L ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.] 6 benzalkonium chloride INACTIVE INGREDIENT F5UM2KM3W7 ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.] 6 edetate disodium INACTIVE INGREDIENT 7FLD91C86K ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.] 6 hydrochloric acid INACTIVE INGREDIENT QTT17582CB ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.] 6 octoxynol-40 INACTIVE INGREDIENT 9T1C662FKS ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.] 6 sodium chloride INACTIVE INGREDIENT 451W47IQ8X ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.] 6 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.] 6 water INACTIVE INGREDIENT 059QF0KO0R ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.] 6 KETOROLAC TROMETHAMINE ACTIVE INGREDIENT 4EVE5946BQ ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [STAT RX USA LLC] 4 KETOROLAC ACTIVE MOIETY YZI5105V0L ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [STAT RX USA LLC] 4 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [STAT RX USA LLC] 4 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [STAT RX USA LLC] 4 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [STAT RX USA LLC] 4 OCTOXYNOL-40 INACTIVE INGREDIENT 9T1C662FKS ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [STAT RX USA LLC] 4 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [STAT RX USA LLC] 4 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [STAT RX USA LLC] 4 WATER INACTIVE INGREDIENT 059QF0KO0R ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [STAT RX USA LLC] 4 KETOROLAC TROMETHAMINE ACTIVE INGREDIENT 4EVE5946BQ ACULAR (KETOROLAC TROMETHAMINE) SOLUTION [REBEL DISTRIBUTORS CORP.] 1 KETOROLAC ACTIVE MOIETY YZI5105V0L ACULAR (KETOROLAC TROMETHAMINE) SOLUTION [REBEL DISTRIBUTORS CORP.] 1 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 ACULAR (KETOROLAC TROMETHAMINE) SOLUTION [REBEL DISTRIBUTORS CORP.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ACULAR (KETOROLAC TROMETHAMINE) SOLUTION [REBEL DISTRIBUTORS CORP.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB ACULAR (KETOROLAC TROMETHAMINE) SOLUTION [REBEL DISTRIBUTORS CORP.] 1 OCTOXYNOL-40 INACTIVE INGREDIENT 9T1C662FKS ACULAR (KETOROLAC TROMETHAMINE) SOLUTION [REBEL DISTRIBUTORS CORP.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X ACULAR (KETOROLAC TROMETHAMINE) SOLUTION [REBEL DISTRIBUTORS CORP.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ACULAR (KETOROLAC TROMETHAMINE) SOLUTION [REBEL DISTRIBUTORS CORP.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ACULAR (KETOROLAC TROMETHAMINE) SOLUTION [REBEL DISTRIBUTORS CORP.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0023-2181 ACULAR (KETOROLAC TROMETHAMINE) SOLUTION/ DROPS [ALLERGAN, INC.] 15 Current NDC, Legacy NDC, 2 package rows 20250410_c94644d3-7b64-4f3d-a0c7-12c77466a0fc.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 Marketing start Marketing end Sample Exclude flag Status 0023-2181-05 00023218105 1 BOTTLE, DROPPER in 1 CARTON (0023-2181-05) / 5 mL in 1 BOTTLE, DROPPER 1992-12-01 0000-00-00 No No Current