Ketorolac Tromethamine
- Product NDC
- 66267-418
- 11-digit product format
- 662670418
- Labeler code
- 66267
- Product ID
- 66267-418_1fa6dc86-663b-c362-e063-6394a90a4c03
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA074754
- Marketing category
- ANDA
- Marketing start
- 1998-06-17
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 10 mg/1
- 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4EVE5946BQ |
| Rxcui | 834022 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 66267-418-20 | 2024-08-15 | C162847 | 48780-1 | 9d75b9d0-9d30-f424-e053-dadaa90a57ce | KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only |
| 66267-418-30 | 2024-08-15 | C162847 | 48780-1 | 9d75b9d0-9d30-f424-e053-dadaa90a57ce | KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only |
| 66267-418-20 | 2024-01-30 | C162847 | 48780-1 | 9d75b9d0-9d30-f424-e053-dadaa90a57ce | KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only |
| 66267-418-30 | 2024-01-30 | C162847 | 48780-1 | 9d75b9d0-9d30-f424-e053-dadaa90a57ce | KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only |
| 66267-418-20 | 2021-05-13 | C162847 | 48780-1 | 9d75b9d0-9d30-f424-e053-dadaa90a57ce | KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only |
| 66267-418-30 | 2021-05-13 | C162847 | 48780-1 | 9d75b9d0-9d30-f424-e053-dadaa90a57ce | KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only |
| 66267-418-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-9d30-f424-e053-dadaa90a57ce | KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only |
| 66267-418-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-9d30-f424-e053-dadaa90a57ce | KETOROLAC TROMETHAMINE TABLETS USP, 10 mg 0314 Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66267-418-20 | Ketorolac Tromethamine | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 4 |
| 66267-418-30 | Ketorolac Tromethamine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66267-418 | KETOROLAC TROMETHAMINE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240816_415a5393-296f-30e3-e054-00144ff8d46c.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 |
|---|
| 66267-418-02 | 66267041802 | 20 TABLET, FILM COATED in 1 BOTTLE (66267-418-02) | 2017-07-27 | 0000-00-00 | No | No | Current |
| 66267-418-08 | 66267041808 | 8 TABLET, FILM COATED in 1 BOTTLE (66267-418-08) | 2017-07-27 | 0000-00-00 | No | No | Current |
| 66267-418-20 | 66267041820 | 20 TABLET, FILM COATED in 1 BOTTLE (66267-418-20) | 2016-11-15 | 0000-00-00 | No | No | Current |
| 66267-418-30 | 66267041830 | 30 TABLET, FILM COATED in 1 BOTTLE (66267-418-30) | 2016-11-15 | 0000-00-00 | No | No | Current |