Diclofenac Sodium
- Product NDC
- 83008-037
- 11-digit product format
- 830080037
- Labeler code
- 83008
- Product ID
- 83008-037_b686004e-bfe6-4125-aea6-b94ed1eb700b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Quality Care Products, LLC
- Application
- ANDA209903
- Marketing category
- ANDA
- Marketing start
- 2023-08-04
- Marketing end
- 2027-04-30
- Substance
- DICLOFENAC SODIUM
- Active strength
- 10 mg/g
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diclofenac Sodium
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICLOFENAC SODIUM | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 855633 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83008-037-00 | Diclofenac Sodium | 1 in 1 CARTON | GEL | 1 | | 4 |
| 83008-037-00 | Diclofenac Sodium | 100 g in 1 TUBE | GEL | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83008-037 | DICLOFENAC SODIUM GEL [QUALITY CARE PRODUCTS, LLC] | 4 | Current NDC, 2 package rows | 20241222_12e1f808-9f24-4f6d-b5bc-12ce0059ab7a.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 |
|---|
| 83008-037-00 | 83008003700 | 1 TUBE in 1 CARTON (83008-037-00) / 100 g in 1 TUBE | 1 tube | 2023-08-04 | 2027-04-30 | No | No | Historical |