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
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 Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4EVE5946BQ |
| Rxcui | 860103 |
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 |
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 |