Berkley and Jensen Naproxen Sodium
- Product NDC
- 68391-368
- 11-digit product format
- 683910368
- Labeler code
- 68391
- Product ID
- 68391-368_4c47d9e4-c0af-44df-ac59-5cac3fb7b084
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- BJWC
- Application
- ANDA074661
- Marketing category
- ANDA
- Marketing start
- 2007-09-17
- Substance
- NAPROXEN SODIUM
- Active strength
- 220 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Berkley and Jensen Naproxen Sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPROXEN SODIUM | 220 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9TN87S3A3C |
| Rxcui | 849574 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68391-368-79 | Berkley and Jensen Naproxen Sodium | 400 in 1 BOTTLE | TABLET, FILM COATED | 400 | | 10 |
| 68391-368-87 | Berkley and Jensen Naproxen Sodium | 300 in 1 BOTTLE | TABLET, FILM COATED | 300 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NAPROXEN SODIUM | ACTIVE INGREDIENT | 9TN87S3A3C | BERKLEY AND JENSEN NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [BJWC] | 4 | |
| NAPROXEN | ACTIVE MOIETY | 57Y76R9ATQ | BERKLEY AND JENSEN NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [BJWC] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | BERKLEY AND JENSEN NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [BJWC] | 4 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | BERKLEY AND JENSEN NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [BJWC] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | BERKLEY AND JENSEN NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [BJWC] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | BERKLEY AND JENSEN NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [BJWC] | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | BERKLEY AND JENSEN NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [BJWC] | 4 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | BERKLEY AND JENSEN NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [BJWC] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | BERKLEY AND JENSEN NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [BJWC] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | BERKLEY AND JENSEN NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [BJWC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68391-368 | BERKLEY AND JENSEN NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [BJWC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20250119_9530b649-3e01-452c-99a6-cff47fa4085b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68391-368-79 | 68391036879 | 400 TABLET, FILM COATED in 1 BOTTLE (68391-368-79) | 2011-04-15 | 0000-00-00 | No | No | Current |
| 68391-368-87 | 68391036887 | 300 TABLET, FILM COATED in 1 BOTTLE (68391-368-87) | 2007-09-17 | 0000-00-00 | No | No | Current |