Diclofenac Sodium Topical Solution
- Product NDC
- 45865-983
- 11-digit product format
- 458650983
- Labeler code
- 45865
- Product ID
- 45865-983_9af147ca-cb18-3194-e053-2a95a90aa0a8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- medsource pharmaceuticals
- Application
- ANDA206715
- Marketing category
- ANDA
- Marketing start
- 2017-11-01
- Marketing end
- 0000-00-00
- Substance
- DICLOFENAC SODIUM
- Active strength
- 16 mg/mL
- 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
- 2020-12-31
- 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 |
|---|
| 45865-983-01 | Diclofenac Sodium Topical Solution | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
| 45865-983-01 | Diclofenac Sodium Topical Solution | 150 mL in 1 BOTTLE, DROPPER | SOLUTION | 150 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45865-983 | DICLOFENAC SODIUM TOPICAL SOLUTION (DICLOFENAC SODIUM) SOLUTION [MEDSOURCE PHARMACEUTICALS] | 1 | Legacy NDC, 2 package rows | 20191231_9af13122-73b2-95de-e053-2995a90a0505.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45865-983-01 | 45865098301 | 1 BOTTLE, DROPPER in 1 CARTON (45865-983-01) > 150 mL in 1 BOTTLE, DROPPER | 2019-12-11 | 0000-00-00 | No | No | Current |