Ketorolac Tromethamine
- Product NDC
- 33261-065
- 11-digit product format
- 332610065
- Labeler code
- 33261
- Product ID
- 33261-065_5a527655-75fd-42b8-b724-ff24d527a240
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA074754
- Marketing category
- ANDA
- Marketing start
- 1998-06-17
- Marketing end
- 0000-00-00
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 |
|---|
| 33261-065-10 | Ketorolac Tromethamine | 10 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 10 | | 1 |
| 33261-065-15 | Ketorolac Tromethamine | 15 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 15 | | 1 |
| 33261-065-20 | Ketorolac Tromethamine | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | | 1 |
| 33261-065-30 | Ketorolac Tromethamine | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
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 [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| KETOROLAC | ACTIVE MOIETY | YZI5105V0L | KETOROLAC TROMETHAMINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | KETOROLAC TROMETHAMINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | KETOROLAC TROMETHAMINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | KETOROLAC TROMETHAMINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | KETOROLAC TROMETHAMINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | KETOROLAC TROMETHAMINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | KETOROLAC TROMETHAMINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | KETOROLAC TROMETHAMINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33261-065 | KETOROLAC TROMETHAMINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 4 package rows | 20140110_11b38f8d-26e0-4614-97ba-722505b0ffb0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 33261-065-10 | 33261006510 | 10 in 1 BOTTLE, PLASTIC | Historical |
| 33261-065-15 | 33261006515 | 15 in 1 BOTTLE, PLASTIC | Historical |
| 33261-065-20 | 33261006520 | 20 in 1 BOTTLE, PLASTIC | Historical |
| 33261-065-30 | 33261006530 | 30 in 1 BOTTLE, PLASTIC | Historical |