Naproxen
- Product NDC
- 42192-619
- 11-digit product format
- 421920619
- Labeler code
- 42192
- Product ID
- 42192-619_47a98b71-a338-b13d-e063-6394a90a96f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Acella Pharmaceuticals, LLC
- Application
- NDA018965
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2020-11-12
- Marketing end
- 2028-01-31
- Substance
- NAPROXEN
- Active strength
- 125 mg/5mL
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naproxen
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPROXEN | 125 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 57Y76R9ATQ |
| Rxcui | 311913 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42192-619-16 | Naproxen | 473 mL in 1 BOTTLE | SUSPENSION | 473 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42192-619 | NAPROXEN SUSPENSION [ACELLA PHARMACEUTICALS, LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20230118_7e6f03fb-4b36-4418-9684-f45637abbb78.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42192-619-16 | 42192061916 | 473 mL in 1 BOTTLE (42192-619-16) | 473 ml | 2020-11-12 | 2028-01-31 | No | No | Current |