Sprix
- Product NDC
- 76519-1017
- 11-digit product format
- 765191017
- Labeler code
- 76519
- Product ID
- 76519-1017_70ee2244-de89-4c89-8a23-b23d2843f281
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ketorolac tromethamine
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Labeler
- H.J. Harkins Company, Inc.
- Application
- NDA022382
- Marketing category
- NDA
- Marketing start
- 2011-04-26
- Marketing end
- 0000-00-00
- Substance
- KETOROLAC TROMETHAMINE
- Active strength
- 16 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]
- 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 |
|---|
| 76519-1017-1 | Sprix | 1 in 1 BOTTLE, SPRAY | SPRAY, METERED | 1 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ketorolac tromethamine | ACTIVE INGREDIENT | 4EVE5946BQ | SPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [H.J. HARKINS COMPANY, INC.] | 1 | |
| ketorolac | ACTIVE MOIETY | YZI5105V0L | SPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [H.J. HARKINS COMPANY, INC.] | 1 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | SPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [H.J. HARKINS COMPANY, INC.] | 1 | |
| POTASSIUM PHOSPHATE, MONOBASIC | INACTIVE INGREDIENT | 4J9FJ0HL51 | SPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [H.J. HARKINS COMPANY, INC.] | 1 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | SPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [H.J. HARKINS COMPANY, INC.] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | SPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [H.J. HARKINS COMPANY, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76519-1017 | SPRIX (KETOROLAC TROMETHAMINE) SPRAY, METERED [H.J. HARKINS COMPANY, INC.] | 1 | Legacy NDC, 1 package rows | 20121031_09a80ee7-274a-4f96-8b42-480436896050.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 76519-1017-1 | 76519101701 | 1 in 1 BOTTLE, SPRAY | Historical |