Diclofenac Sodium
- Product NDC
- 72888-111
- 11-digit product format
- 728880111
- Labeler code
- 72888
- Product ID
- 72888-111_3904a832-bc2f-1d96-e063-6294a90a0cd0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Advagen Pharma Ltd
- Application
- ANDA216548
- Marketing category
- ANDA
- Marketing start
- 2023-05-11
- Substance
- DICLOFENAC SODIUM
- Active strength
- 75 mg/1
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diclofenac Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICLOFENAC SODIUM | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 855664, 855906, 855926 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72888-111-00 | Diclofenac Sodium | 1000 in 1 BOTTLE | TABLET, DELAYED RELEASE | 1000 | | 4 |
| 72888-111-01 | Diclofenac Sodium | 100 in 1 BOTTLE | TABLET, DELAYED RELEASE | 100 | | 4 |
| 72888-111-05 | Diclofenac Sodium | 500 in 1 BOTTLE | TABLET, DELAYED RELEASE | 500 | | 4 |
| 72888-111-30 | Diclofenac Sodium | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 4 |
| 72888-111-60 | Diclofenac Sodium | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72888-111 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [ADVAGEN PHARMA LTD] | 3 | Current NDC, 5 package rows | 20230929_ac2b4060-a5da-4ddf-a734-2ff58a1f98c9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72888-111-00 | 72888011100 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-111-00) | 2023-06-01 | No | No | Historical |
| 72888-111-01 | 72888011101 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-111-01) | 2023-06-01 | No | No | Historical |
| 72888-111-05 | 72888011105 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-111-05) | 2023-08-01 | No | No | Historical |
| 72888-111-30 | 72888011130 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-111-30) | 2023-06-01 | No | No | Historical |
| 72888-111-60 | 72888011160 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-111-60) | 2023-06-01 | No | No | Historical |