Diflunisal
- Product NDC
- 62135-456
- 11-digit product format
- 621350456
- Labeler code
- 62135
- Product ID
- 62135-456_242086f3-3373-fac8-e063-6394a90a82ab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diflunisal
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA202845
- Marketing category
- ANDA
- Marketing start
- 2012-03-08
- Substance
- DIFLUNISAL
- Active strength
- 500 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
- Diflunisal
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIFLUNISAL | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7C546U4DEN |
| Rxcui | 197603 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-456-60 | Diflunisal | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-456 | DIFLUNISAL TABLET, FILM COATED [CHARTWELL RX, LLC] | 2 | Current NDC, 1 package rows | 20241012_2043bab8-87c9-45ce-88c7-383f0d4c4b64.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 62135-456-60 | 62135045660 | 60 TABLET, FILM COATED in 1 BOTTLE (62135-456-60) | 2023-01-31 | No | No | Current |