NDC 59115-002-99 - Naproxen Sodium
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 59115-002
- Requested NDC
- 59115-002-99
- Package NDCs from labels
- 59115-002-99
- Manufacturer
- Hikma Pharmaceutical | Al Hikma Pharmaceuticals LLC
- Effective date
- 2012-07-16
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Naproxen Sodium - Hikma Pharmaceutical | Al Hikma Pharmaceuticals LLC | Hikma Pharmaceutical | Al Hikma Pharmaceuticals LLC | 2012-07-16 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| NAPROXEN SODIUM | ACTIVE INGREDIENT | 9TN87S3A3C | NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL] | 3 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL] | 3 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL] | 3 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL] | 3 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Teething | ARNICA MONTANA, TRIFOLIUM PRATENSE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CHAMOMILLA, KREOSOTUM, SILICEA | BioActive Nutritional, Inc. | f39c9feb-f567-43a2-a026-2a581aeeed9d | 2016-07-27 | Warnings | ETJ7Z6XBU4 |
| efde630c-d2fc-4da7-a7d1-45d9dba86b67 | 6782632c-c8a0-4cab-89af-9d1c5f392c8f | 2012-07-16 | Boxed warning, Warnings, Adverse reactions | efde630c-d2fc-4da7-a7d1-45d9dba86b67 6782632c-c8a0-4cab-89af-9d1c5f392c8f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.