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
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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4EVE5946BQ |
| Rxcui | 860107, 860109 |
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 |
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 |