Naproxen
- Product NDC
- 21695-343
- 11-digit product format
- 216950343
- Labeler code
- 21695
- Product ID
- 21695-343_afebcc90-e2b5-416d-a041-db2dd593a648
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA075227
- Marketing category
- ANDA
- Marketing start
- 2010-06-02
- 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 |
|---|
| 21695-343-30 | Naproxen | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 1 |
| 21695-343-60 | 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 [REBEL DISTRIBUTORS CORP] | 1 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-343 | NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 2 package rows | 20110121_afebcc90-e2b5-416d-a041-db2dd593a648.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-343-30 | 21695034330 | 30 in 1 BOTTLE | Historical |
| 21695-343-60 | 21695034360 | 60 in 1 BOTTLE | Historical |