LOFENA
- Product NDC
- 15370-180
- 11-digit product format
- 153700180
- Labeler code
- 15370
- Product ID
- 15370-180_2a1bac02-dabb-4afe-a378-bc4451dcb0cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DICLOFENAC POTASSIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Carwin Pharmaceutical Associates, LLC
- Application
- ANDA076561
- Marketing category
- ANDA
- Marketing start
- 2021-10-25
- Substance
- DICLOFENAC POTASSIUM
- Active strength
- 25 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], 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
- LOFENA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICLOFENAC POTASSIUM | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L4D5UA6CB4 |
| Rxcui | 857702, 2584350 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 15370-180-10 | LOFENA | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
| 15370-180-60 | LOFENA | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 15370-180 | LOFENA (DICLOFENAC POTASSIUM) TABLET, FILM COATED [CARWIN PHARMACEUTICAL ASSOCIATES, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250410_49bd64cc-5edb-44f2-8e24-1249f6a76663.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 |
|---|
| 15370-180-10 | 15370018010 | 1000 TABLET, FILM COATED in 1 BOTTLE (15370-180-10) | 2021-10-25 | 0000-00-00 | No | No | Current |
| 15370-180-60 | 15370018060 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15370-180-60) | 2021-10-25 | 0000-00-00 | No | No | Current |