Diclofenac Sodium D/R
- Product NDC
- 61919-074
- 11-digit product format
- 619190074
- Labeler code
- 61919
- Product ID
- 61919-074_c42fea0c-d812-061c-e053-2995a90a9b8d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium D/R
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Direct RX
- Application
- ANDA075185
- Marketing category
- ANDA
- Marketing start
- 2014-01-01
- Marketing end
- 0000-00-00
- Substance
- DICLOFENAC SODIUM
- Active strength
- 50 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61919-074-30 | Diclofenac Sodium D/R | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 12 |
| 61919-074-60 | Diclofenac Sodium D/R | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | | 12 |
| 61919-074-90 | Diclofenac Sodium D/R | 90 in 1 BOTTLE | TABLET, DELAYED RELEASE | 90 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DICLOFENAC SODIUM | ACTIVE INGREDIENT | QTG126297Q | DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX] | 1 | |
| DICLOFENAC | ACTIVE MOIETY | 144O8QL0L1 | DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX] | 1 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | INACTIVE INGREDIENT | 74G4R6TH13 | DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX] | 1 | |
| POLYETHYLENE GLYCOL 2000 | INACTIVE INGREDIENT | HAF0412YIT | DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61919-074 | DICLOFENAC SODIUM D/R TABLET, DELAYED RELEASE [DIRECT RX] | 12 | Legacy NDC, 3 package rows | 20230408_2ae3c1e2-f053-4efb-9597-eeac4998d23f.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 |
|---|
| 61919-074-30 | 61919007430 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-074-30) | 2014-01-01 | 0000-00-00 | No | No | Current |
| 61919-074-60 | 61919007460 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-074-60) | 2014-01-01 | 0000-00-00 | No | No | Current |
| 61919-074-90 | 61919007490 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (61919-074-90) | 2014-01-01 | 0000-00-00 | No | No | Current |