diclofenac sodium
- Product NDC
- 21695-039
- 11-digit product format
- 216950039
- Labeler code
- 21695
- Product ID
- 21695-039_6b7fb6b7-2f58-4cb6-b48f-e9b4cf292365
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diclofenac sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA074514
- Marketing category
- ANDA
- Marketing start
- 1996-03-26
- 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
- E
- Listing certified through
- 2017-12-31
- 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 |
|---|
| 21695-039-20 | diclofenac sodium | 20 in 1 BOTTLE | TABLET, DELAYED RELEASE | 20 | | 1 |
| 21695-039-30 | diclofenac sodium | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 1 |
| 21695-039-60 | diclofenac sodium | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 1 |
| 21695-039-90 | diclofenac sodium | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| diclofenac sodium | ACTIVE INGREDIENT | QTG126297Q | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| diclofenac | ACTIVE MOIETY | 144O8QL0L1 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| DIHYDROXYALUMINUM AMINOACETATE | INACTIVE INGREDIENT | DO250MG0W6 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| POLYVINYL ACETATE PHTHALATE | INACTIVE INGREDIENT | 58QVG85GW3 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM ALGINATE | INACTIVE INGREDIENT | C269C4G2ZQ | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| stearic acid | INACTIVE INGREDIENT | 4ELV7Z65AP | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-039 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 4 package rows | 20110726_6b7fb6b7-2f58-4cb6-b48f-e9b4cf292365.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-039-20 | 21695003920 | 20 in 1 BOTTLE | Historical |
| 21695-039-30 | 21695003930 | 30 in 1 BOTTLE | Historical |
| 21695-039-60 | 21695003960 | 60 in 1 BOTTLE | Historical |
| 21695-039-90 | 21695003990 | 90 in 1 BOTTLE | Historical |