Diclofenac Sodium
- Product NDC
- 63187-222
- 11-digit product format
- 631870222
- Labeler code
- 63187
- Product ID
- 63187-222_108a4ddb-0e11-472d-989a-5617e8823008
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA075185
- Marketing category
- ANDA
- Marketing start
- 1998-11-13
- Substance
- DICLOFENAC SODIUM
- Active strength
- 75 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diclofenac Sodium
- Brand name suffix
- Delayed Release
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICLOFENAC SODIUM | 75 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 855926 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-222-15 | Diclofenac SodiumDelayed Release | 15 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 15 | | 6 |
| 63187-222-30 | Diclofenac SodiumDelayed Release | 30 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 30 | | 6 |
| 63187-222-60 | Diclofenac SodiumDelayed Release | 60 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 60 | | 6 |
| 63187-222-90 | Diclofenac SodiumDelayed Release | 90 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 90 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Diclofenac Sodium | ACTIVE INGREDIENT | QTG126297Q | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| Diclofenac | ACTIVE MOIETY | 144O8QL0L1 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | INACTIVE INGREDIENT | 74G4R6TH13 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| POLYETHYLENE GLYCOL 2000 | INACTIVE INGREDIENT | HAF0412YIT | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-222 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PROFICIENT RX LP] | 6 | Current NDC, Legacy NDC, 4 package rows | 20230306_73a46413-ecbc-4453-814d-bec955b375d2.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 |
|---|
| 63187-222-15 | 63187022215 | 15 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (63187-222-15) | 2014-09-01 | 0000-00-00 | No | No | Current |
| 63187-222-30 | 63187022230 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (63187-222-30) | 2014-09-01 | 0000-00-00 | No | No | Current |
| 63187-222-60 | 63187022260 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (63187-222-60) | 2014-09-01 | 0000-00-00 | No | No | Current |
| 63187-222-90 | 63187022290 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (63187-222-90) | 2014-09-01 | 0000-00-00 | No | No | Current |