Diclofenac Sodium
- Product NDC
- 0378-6281
- 11-digit product format
- 003786281
- Labeler code
- 0378
- Product ID
- 0378-6281_a6f20b0b-84e7-44d8-982c-e93ea4509e9e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diclofenac sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA075281
- Marketing category
- ANDA
- Marketing start
- 2010-05-18
- Marketing end
- 2020-09-30
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
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 [STAT RX USA LLC] | 4 | |
| DICLOFENAC | ACTIVE MOIETY | 144O8QL0L1 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC] | 4 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC] | 4 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC] | 4 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC] | 4 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC] | 4 | |
| METHACRYLIC ACID | INACTIVE INGREDIENT | 1CS02G8656 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC] | 4 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC] | 4 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC] | 4 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [STAT RX USA LLC] | 4 | |
DailyMed RxNorm Mappings#