Belmora Flanax
- Product NDC
- 27854-555
- 11-digit product format
- 278540555
- Labeler code
- 27854
- Product ID
- 27854-555_1318469f-79ca-4092-8617-e803250c4266
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Belmora LLC
- Application
- ANDA090545
- Marketing category
- ANDA
- Marketing start
- 2020-07-20
- 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
- Belmora Flanax
- 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 |
|---|
| 27854-555-01 | Belmora Flanax | 1 in 1 CARTON | TABLET | 1 | | 10 |
| 27854-555-01 | Belmora Flanax | 24 in 1 BOTTLE | TABLET | 24 | | 10 |
| 27854-555-02 | Belmora Flanax | 1 in 1 PACKET | TABLET | 1 | | 10 |
| 27854-555-02 | Belmora Flanax | 40 in 1 BOX | TABLET | 40 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 27854-555 | BELMORA FLANAX (NAPROXEN SODIUM) TABLET [BELMORA LLC] | 10 | Current NDC, Legacy NDC, 4 package rows | 20241010_a44b8a82-251d-d5e8-e053-2a95a90a72f7.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 |
|---|
| 27854-555-01 | 27854055501 | 1 BOTTLE in 1 CARTON (27854-555-01) / 24 TABLET in 1 BOTTLE | 1 bottle | 2020-09-14 | 0000-00-00 | No | No | Current |
| 27854-555-02 | 27854055502 | 40 PACKET in 1 BOX (27854-555-02) / 1 TABLET in 1 PACKET | 40 packet | 2020-07-20 | 0000-00-00 | No | No | Current |