Diclofenac Sodium
- Product NDC
- 0378-8750
- 11-digit product format
- 003788750
- Labeler code
- 0378
- Product ID
- 0378-8750_c93658cc-cdd1-4224-a4b3-76c19574e6b8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diclofenac
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA204306
- Marketing category
- ANDA
- Marketing start
- 2019-05-06
- Marketing end
- 2022-09-30
- Substance
- DICLOFENAC SODIUM
- Active strength
- 10 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
- 0000-00-00
- 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 |
|---|
| 0378-8750-06 | 00378875006 | 1 TUBE in 1 CARTON (0378-8750-06) > 100 g in 1 TUBE | 1 tube | 2019-05-06 | 2022-09-30 | No | No | Current |