KETOROLAC TROMETHAMINE
- Product NDC
- 61919-138
- 11-digit product format
- 619190138
- Labeler code
- 61919
- Product ID
- 61919-138_f20279e7-251d-bd10-e053-2995a90af47d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- KETOROLAC TROMETHAMINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA074754
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- Marketing end
- 0000-00-00
- 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
- 2024-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61919-138-10 | KETOROLAC TROMETHAMINE | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 6 |
| 61919-138-15 | KETOROLAC TROMETHAMINE | 15 in 1 BOTTLE | TABLET, FILM COATED | 15 | | 6 |
| 61919-138-20 | KETOROLAC TROMETHAMINE | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 6 |
| 61919-138-30 | KETOROLAC TROMETHAMINE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| KETOROLAC TROMETHAMINE | ACTIVE INGREDIENT | 4EVE5946BQ | KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT RX] | 2 | |
| KETOROLAC | ACTIVE MOIETY | YZI5105V0L | KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT RX] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT RX] | 2 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT RX] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT RX] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT RX] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT RX] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT RX] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT RX] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-138 | KETOROLAC TROMETHAMINE TABLET, FILM COATED [DIRECT RX] | 6 | Legacy NDC, 4 package rows | 20230412_a42517a0-245e-44ec-b9fc-cf4e4b4a8989.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 |
|---|
| 61919-138-10 | 61919013810 | 10 TABLET, FILM COATED in 1 BOTTLE (61919-138-10) | 2015-01-01 | 0000-00-00 | No | No | Current |
| 61919-138-15 | 61919013815 | 15 TABLET, FILM COATED in 1 BOTTLE (61919-138-15) | 2015-12-08 | 0000-00-00 | No | No | Current |
| 61919-138-20 | 61919013820 | 20 TABLET, FILM COATED in 1 BOTTLE (61919-138-20) | 2015-01-01 | 0000-00-00 | No | No | Current |
| 61919-138-30 | 61919013830 | 30 TABLET, FILM COATED in 1 BOTTLE (61919-138-30) | 2015-01-01 | 0000-00-00 | No | No | Current |