DICLOFENAC SODIUM
- Product NDC
- 61919-468
- 11-digit product format
- 619190468
- Labeler code
- 61919
- Product ID
- 61919-468_45fd0a74-412d-44bb-8e72-f8a65b2ce974
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DICLOFENAC SODIUM
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Direct RX
- Application
- ANDA076201
- Marketing category
- ANDA
- Marketing start
- 2015-01-01
- 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
- 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 |
|---|
| 61919-468-30 | DICLOFENAC SODIUM | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 1 |
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 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | 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 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX] | 1 | |
| COPOVIDONE K25-31 | INACTIVE INGREDIENT | D9C330MD8B | DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | 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 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 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 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 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 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-468 | DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED RELEASE [DIRECT RX] | 1 | Legacy NDC, 1 package rows | 20150630_7cf9cdc3-6837-4b64-b967-9d15f3b0bdc4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 61919-468-30 | 61919046830 | 30 in 1 BOTTLE | Historical |