Naproxen Sodium
- Product NDC
- 43598-071
- 11-digit product format
- 435980071
- Labeler code
- 43598
- Product ID
- 43598-071_c94f5885-67ab-4e95-df53-a58f119c504b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Dr.Reddy's Laboratories Inc
- Application
- ANDA075168
- Marketing category
- ANDA
- Marketing start
- 2021-12-10
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naproxen Sodium
- Brand name suffix
- Headache Pain
- Listing expiration
- 2026-12-31
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 |
|---|
| 43598-071-01 | Naproxen Sodium Headache Pain | 1 in 1 CARTON | TABLET, COATED | 1 | | 6 |
| 43598-071-01 | Naproxen Sodium Headache Pain | 100 in 1 BOTTLE | TABLET, COATED | 100 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-071 | NAPROXEN SODIUM HEADACHE PAIN (NAPROXEN SODIUM) TABLET, COATED NAPROXEN SODIUM BACK AND MUSCLE PAIN (NAPROXEN SODIUM) TABLET, COATED [DR.REDDY'S LABORATORIES INC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20221223_12e45b43-eca2-73f4-1d68-07d4238f8c70.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 |
|---|
| 43598-071-01 | 43598007101 | 1 BOTTLE in 1 CARTON (43598-071-01) / 100 TABLET, COATED in 1 BOTTLE | 1 bottle | 2021-12-10 | 0000-00-00 | No | No | Current |