Diclofenac Sodium
- Product NDC
- 53002-5360
- 11-digit product format
- 530025360
- Labeler code
- 53002
- Product ID
- 53002-5360_dd4e3831-d04e-4504-b0e4-92f550a4b1d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA075185
- Marketing category
- ANDA
- Marketing start
- 1998-11-13
- Marketing end
- 0000-00-00
- Substance
- DICLOFENAC SODIUM
- Active strength
- 75 mg/1
- 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 |
|---|
| 53002-5360-1 | Diclofenac Sodium Delayed Release | 10 in 1 BOTTLE | TABLET, DELAYED RELEASE | 10 | | 7 |
| 53002-5360-2 | Diclofenac Sodium Delayed Release | 20 in 1 BOTTLE | TABLET, DELAYED RELEASE | 20 | | 7 |
| 53002-5360-3 | Diclofenac Sodium Delayed Release | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 7 |
| 53002-5360-5 | Diclofenac Sodium Delayed Release | 15 in 1 BOTTLE | TABLET, DELAYED RELEASE | 15 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-5360 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [RPK PHARMACEUTICALS, INC.] | 7 | Legacy NDC, 4 package rows | 20230609_89ccfc76-245f-4604-bc1d-9115c657c340.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 |
|---|
| 53002-5360-1 | 53002536001 | 10 TABLET, DELAYED RELEASE in 1 BOTTLE (53002-5360-1) | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-5360-2 | 53002536002 | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (53002-5360-2) | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-5360-3 | 53002536003 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (53002-5360-3) | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-5360-5 | 53002536005 | 15 TABLET, DELAYED RELEASE in 1 BOTTLE (53002-5360-5) | 2018-10-01 | 0000-00-00 | No | No | Current |