KETOROLAC TROMETHAMINE
- Product NDC
- 61314-126
- 11-digit product format
- 613140126
- Labeler code
- 61314
- Product ID
- 61314-126_2833a9fe-4416-4012-8d2c-c9d5090fd2e7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Sandoz Inc
- Application
- ANDA076583
- Marketing category
- ANDA
- Marketing start
- 2009-11-05
- 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
- KETOROLAC TROMETHAMINE
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61314-126-05 | KETOROLAC TROMETHAMINE | 1 in 1 CARTON | SOLUTION | 1 | | 9 |
| 61314-126-05 | KETOROLAC TROMETHAMINE | 5 mL in 1 BOTTLE | SOLUTION | 5 | | 9 |
| 61314-126-10 | KETOROLAC TROMETHAMINE | 1 in 1 CARTON | SOLUTION | 1 | | 9 |
| 61314-126-10 | KETOROLAC TROMETHAMINE | 10 mL in 1 BOTTLE | SOLUTION | 10 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| KETOROLAC TROMETHAMINE | ACTIVE INGREDIENT | 4EVE5946BQ | KETOROLAC TROMETHAMINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 3 | |
| KETOROLAC TROMETHAMINE | ACTIVE MOIETY | 4EVE5946BQ | KETOROLAC TROMETHAMINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 3 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | KETOROLAC TROMETHAMINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 3 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | KETOROLAC TROMETHAMINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 3 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | KETOROLAC TROMETHAMINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 3 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | KETOROLAC TROMETHAMINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 3 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | KETOROLAC TROMETHAMINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | KETOROLAC TROMETHAMINE SOLUTION [FALCON PHARMACEUTICALS, LTD.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61314-126 | KETOROLAC TROMETHAMINE SOLUTION [SANDOZ INC] | 8 | Current NDC, Legacy NDC, 4 package rows | 20220212_79e29a86-1b44-4d95-8d84-5a2e8f23ddcf.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61314-126-05 | 61314012605 | 1 BOTTLE in 1 CARTON (61314-126-05) / 5 mL in 1 BOTTLE | 1 bottle | 2009-11-05 | 0000-00-00 | No | No | Current |
| 61314-126-10 | 61314012610 | 1 BOTTLE in 1 CARTON (61314-126-10) / 10 mL in 1 BOTTLE | 1 bottle | 2009-11-05 | 0000-00-00 | No | No | Current |