Naproxen Sodium PM
- Product NDC
- 70677-0064
- 11-digit product format
- 706770064
- Labeler code
- 70677
- Product ID
- 70677-0064_eb781b4d-79e1-48e2-b903-57b82e006bef
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Strategic Sourcing Services LLC
- Application
- ANDA209726
- Marketing category
- ANDA
- Marketing start
- 2018-12-31
- Marketing end
- 2026-12-31
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
- Active strength
- 25; 220 mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naproxen Sodium PM
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
| NAPROXEN SODIUM | 220 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TC2D6JAD40, 9TN87S3A3C |
| Rxcui | 1550957 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70677-0064-1 | Naproxen Sodium PM | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | | 4 |
| 70677-0064-1 | Naproxen Sodium PM | 1 in 1 BOX | TABLET | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70677-0064 | NAPROXEN SODIUM PM (NAPROXEN SODIUM) TABLET [STRATEGIC SOURCING SERVICES LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20221116_03a331d8-c957-4949-894f-51d9bd15e0d0.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 |
|---|
| 70677-0064-1 | 70677006401 | 1 BOTTLE, PLASTIC in 1 BOX (70677-0064-1) / 20 TABLET in 1 BOTTLE, PLASTIC | 2018-12-31 | 2026-12-31 | No | No | Current |