Naproxen
- Product NDC
- 52959-516
- 11-digit product format
- 529590516
- Labeler code
- 52959
- Product ID
- 52959-516_8aaccad1-9c53-4d0d-a05f-b1a1f7c77d1f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- H.J. Harkins Company, Inc.
- Application
- ANDA075227
- Marketing category
- ANDA
- Marketing start
- 2010-09-23
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [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 |
|---|
| 52959-516-02 | Naproxen | 120 in 1 BOTTLE | TABLET, DELAYED RELEASE | 120 | | 1 |
| 52959-516-10 | Naproxen | 10 in 1 BOTTLE | TABLET, DELAYED RELEASE | 10 | | 1 |
| 52959-516-14 | Naproxen | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | | 1 |
| 52959-516-15 | Naproxen | 15 in 1 BOTTLE | TABLET, DELAYED RELEASE | 15 | | 1 |
| 52959-516-20 | Naproxen | 20 in 1 BOTTLE | TABLET, DELAYED RELEASE | 20 | | 1 |
| 52959-516-30 | Naproxen | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 1 |
| 52959-516-40 | Naproxen | 40 in 1 BOTTLE | TABLET, DELAYED RELEASE | 40 | | 1 |
| 52959-516-42 | Naproxen | 42 in 1 BOTTLE | TABLET, DELAYED RELEASE | 42 | | 1 |
| 52959-516-60 | Naproxen | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NAPROXEN | ACTIVE INGREDIENT | 57Y76R9ATQ | NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| POVIDONE K90 | INACTIVE INGREDIENT | RDH86HJV5Z | NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52959-516 | NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.] | 1 | Legacy NDC, 9 package rows | 20111207_cce0199c-40e9-4c8c-b04c-c2b969e9a5ba.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 52959-516-02 | 52959051602 | 120 in 1 BOTTLE | Historical |
| 52959-516-10 | 52959051610 | 10 in 1 BOTTLE | Historical |
| 52959-516-14 | 52959051614 | 14 in 1 BOTTLE | Historical |
| 52959-516-15 | 52959051615 | 15 in 1 BOTTLE | Historical |
| 52959-516-20 | 52959051620 | 20 in 1 BOTTLE | Historical |
| 52959-516-30 | 52959051630 | 30 in 1 BOTTLE | Historical |
| 52959-516-40 | 52959051640 | 40 in 1 BOTTLE | Historical |
| 52959-516-42 | 52959051642 | 42 in 1 BOTTLE | Historical |
| 52959-516-60 | 52959051660 | 60 in 1 BOTTLE | Historical |