Naproxen
- Product NDC
- 31722-339
- 11-digit product format
- 317220339
- Labeler code
- 31722
- Product ID
- 31722-339_35bc8579-bca9-46a2-9303-5bcb760470d6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals
- Application
- ANDA091432
- Marketing category
- ANDA
- Marketing start
- 2012-01-23
- 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 |
|---|
| 31722-339-01 | Naproxendelayed release | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 31722-339-05 | Naproxendelayed release | 24 in 1 CASE | TABLET | 24 | | 1 |
| 31722-339-10 | Naproxendelayed release | 500 in 1 BOTTLE | TABLET | 500 | | 1 |
| 31722-339-50 | Naproxendelayed release | 12 in 1 CASE | TABLET | 12 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NAPROXEN | ACTIVE INGREDIENT | 57Y76R9ATQ | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.] | 2 | |
| NAPROXEN | ACTIVE INGREDIENT | 57Y76R9ATQ | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS] | 1 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS] | 1 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-339 | NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS] | 1 | Legacy NDC, 4 package rows | 20120202_cb3897b7-d4f1-4081-bb3c-e5e270a84930.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 31722-339-01 | 31722033901 | 100 in 1 BOTTLE | Historical |
| 31722-339-05 | 31722033905 | 24 in 1 CASE | Historical |
| 31722-339-10 | 31722033910 | 500 in 1 BOTTLE | Historical |
| 31722-339-50 | 31722033950 | 12 in 1 CASE | Historical |