DICLOFENAC SODIUM
- Product NDC
- 53149-4901
- 11-digit product format
- 531494901
- Labeler code
- 53149
- Product ID
- 53149-4901_88f33e85-6bf1-4f3f-b46b-39ff6509edc1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diclofenac sodium
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- All Pharma, LLC
- Application
- ANDA208301
- Marketing category
- ANDA
- Marketing start
- 2016-09-13
- Marketing end
- 0000-00-00
- Substance
- DICLOFENAC SODIUM
- Active strength
- 30 mg/g
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53149-4901-1 | DICLOFENAC SODIUM | 100 g in 1 TUBE | GEL | 100 | | 5 |
| 53149-4901-1 | DICLOFENAC SODIUM | 1 in 1 CARTON | GEL | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53149-4901 | DICLOFENAC SODIUM GEL [ALL PHARMA, LLC] | 5 | Legacy NDC, 2 package rows | 20200117_a90e04dc-8ede-4852-9ea5-45bd249dfa1f.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 |
|---|
| 53149-4901-1 | 53149490101 | 1 TUBE in 1 CARTON (53149-4901-1) > 100 g in 1 TUBE | 1 tube | 2018-09-06 | 0000-00-00 | No | No | Current |