DICLOFENAC SODIUM
- Product NDC
- 45802-160
- 11-digit product format
- 458020160
- Labeler code
- 45802
- Product ID
- 45802-160_9ffa34f7-45c2-4dae-9805-195e0f99f087
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diclofenac sodium
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA211253
- Marketing category
- ANDA
- Marketing start
- 2019-05-20
- Marketing end
- 0000-00-00
- 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
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45802-160-00 | 45802016000 | 1 TUBE in 1 CARTON (45802-160-00) > 100 g in 1 TUBE | 1 tube | 2019-05-20 | 0000-00-00 | No | No | Current |