Ketorolac Tromethamine
- Product NDC
- 68387-440
- 11-digit product format
- 683870440
- Labeler code
- 68387
- Product ID
- 68387-440_2f99c62e-06ed-4e9b-8e53-18d9a85e1e7d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ketorolac Tromethamine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Keltman Pharmaceuticals Inc.
- Application
- ANDA074754
- Marketing category
- ANDA
- Marketing start
- 2010-04-20
- Marketing end
- 0000-00-00
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 10 mg/1
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 68387-440-20 | Ketorolac Tromethamine | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | | 2 |
| 68387-440-30 | Ketorolac Tromethamine | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 2 |
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 [KELTMAN PHARMACEUTICALS INC.] | 2 | |
| KETOROLAC TROMETHAMINE | ACTIVE MOIETY | 4EVE5946BQ | KETOROLAC TROMETHAMINE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | KETOROLAC TROMETHAMINE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] | 2 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | KETOROLAC TROMETHAMINE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] | 2 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | KETOROLAC TROMETHAMINE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | KETOROLAC TROMETHAMINE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | KETOROLAC TROMETHAMINE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] | 2 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | KETOROLAC TROMETHAMINE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | KETOROLAC TROMETHAMINE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68387-440 | KETOROLAC TROMETHAMINE TABLET, FILM COATED [KELTMAN PHARMACEUTICALS INC.] | 2 | Legacy NDC, 2 package rows | 20101013_9a6df709-e016-44e1-8e1d-dea46689c3c8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 68387-440-20 | 68387044020 | 20 in 1 BOTTLE, PLASTIC | Historical |
| 68387-440-30 | 68387044030 | 30 in 1 BOTTLE, PLASTIC | Historical |