DICLOFENAC SODIUM
- Product NDC
- 61919-838
- 11-digit product format
- 619190838
- Labeler code
- 61919
- Product ID
- 61919-838_9c93a06e-b8d1-4079-e053-2a95a90ac067
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DICLOFENAC SODIUM
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- DIRECT RX
- Application
- ANDA075910
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- Marketing end
- 0000-00-00
- Substance
- DICLOFENAC SODIUM
- Active strength
- 100 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 |
|---|
| 61919-838-30 | DICLOFENAC SODIUM | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 3 |
| 61919-838-60 | DICLOFENAC SODIUM | 60 in 1 PACKAGE | TABLET, FILM COATED, EXTENDED RE | 60 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DICLOFENAC SODIUM | ACTIVE INGREDIENT | QTG126297Q | DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX] | 1 | |
| DICLOFENAC | ACTIVE MOIETY | 144O8QL0L1 | DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX] | 1 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX] | 1 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX] | 1 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX] | 1 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-838 | DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX] | 3 | Legacy NDC, 2 package rows | 20200128_74bb5cb3-03e0-4dbf-9b8a-f67417538e4f.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 |
|---|
| 61919-838-30 | 61919083830 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (61919-838-30) | 2014-01-01 | 0000-00-00 | No | No | Current |
| 61919-838-60 | 61919083860 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 PACKAGE (61919-838-60) | 2014-01-01 | 0000-00-00 | No | No | Current |