Naproxen
- Product NDC
- 69097-851
- 11-digit product format
- 690970851
- Labeler code
- 69097
- Product ID
- 69097-851_dcfba184-4397-4934-9392-2ac42f65e9e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Cipla USA Inc.
- Application
- ANDA091432
- Marketing category
- ANDA
- Marketing start
- 2016-07-05
- Substance
- NAPROXEN
- Active strength
- 375 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naproxen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPROXEN | 375 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 57Y76R9ATQ |
| Rxcui | 311915, 603103 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69097-851-07 | Naproxen | 100 in 1 BOTTLE | TABLET, DELAYED RELEASE | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69097-851 | NAPROXEN TABLET, DELAYED RELEASE [CIPLA USA INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20190828_e06c2b43-9882-442e-8413-10d9a33aecb9.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 |
|---|
| 69097-851-07 | 69097085107 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (69097-851-07) | 2016-07-05 | 0000-00-00 | No | No | Current |