KETOROLAC TROMETHAMINE
- Product NDC
- 72789-437
- 11-digit product format
- 727890437
- Labeler code
- 72789
- Product ID
- 72789-437_3a25208f-aeec-f466-e063-6294a90a92ad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- KETOROLAC TROMETHAMINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA215745
- Marketing category
- ANDA
- Marketing start
- 2024-03-01
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72789-437-01 | KETOROLAC TROMETHAMINE | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 12 |
| 72789-437-10 | KETOROLAC TROMETHAMINE | 10 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 10 | | 12 |
| 72789-437-20 | KETOROLAC TROMETHAMINE | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-437 | KETOROLAC TROMETHAMINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 11 | Current NDC, 3 package rows | 20241114_862dd7b7-8ed5-42bf-870e-a45b86740226.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-437-01 | 72789043701 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-437-01) | 2024-10-04 | No | No | Current |
| 72789-437-10 | 72789043710 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-437-10) | 2024-11-11 | No | No | Current |
| 72789-437-20 | 72789043720 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-437-20) | 2024-10-10 | No | No | Current |