Ketorolac Tromethamine
- Product NDC
- 63187-777
- 11-digit product format
- 631870777
- Labeler code
- 63187
- Product ID
- 63187-777_df37d0b1-1981-4c46-a3a6-60712c06370c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Proficient Rx LP
- Application
- ANDA076109
- Marketing category
- ANDA
- Marketing start
- 2009-12-07
- 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 |
|---|
| 63187-777-05 | Ketorolac Tromethamine | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 4 |
| 63187-777-05 | Ketorolac Tromethamine | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 4 |
| 63187-777-10 | Ketorolac Tromethamine | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | | 4 |
| 63187-777-10 | Ketorolac Tromethamine | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-777 | KETOROLAC TROMETHAMINE SOLUTION/ DROPS [PROFICIENT RX LP] | 4 | Current NDC, Legacy NDC, 4 package rows | 20221110_2f27e304-7a96-47b6-8ef1-8a649c25abcf.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 |
|---|
| 63187-777-05 | 63187077705 | 1 BOTTLE, DROPPER in 1 CARTON (63187-777-05) / 5 mL in 1 BOTTLE, DROPPER | 2016-11-01 | 0000-00-00 | No | No | Current |
| 63187-777-10 | 63187077710 | 1 BOTTLE, DROPPER in 1 CARTON (63187-777-10) / 10 mL in 1 BOTTLE, DROPPER | 2016-11-01 | 0000-00-00 | No | No | Current |