Diclofenac Potassium
- Product NDC
- 10135-806
- 11-digit product format
- 101350806
- Labeler code
- 10135
- Product ID
- 10135-806_30c7197b-7111-d8a7-e063-6394a90addfb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diclofenac potassium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals, Inc.
- Application
- ANDA075463
- Marketing category
- ANDA
- Marketing start
- 2025-03-01
- Substance
- DICLOFENAC POTASSIUM
- Active strength
- 50 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
- Diclofenac Potassium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICLOFENAC POTASSIUM | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L4D5UA6CB4 |
| Rxcui | 855942 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10135-806-01 | Diclofenac Potassium | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10135-806 | DICLOFENAC POTASSIUM TABLET, FILM COATED [MARLEX PHARMACEUTICALS, INC.] | 1 | Current NDC, 1 package rows | 20250323_30c7197b-7110-d8a7-e063-6394a90addfb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 10135-806-01 | 10135080601 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-806-01) | 2025-03-01 | No | No | Historical |