Diclofenac Sodium
- Product NDC
- 61442-101
- 11-digit product format
- 614420101
- Labeler code
- 61442
- Product ID
- 61442-101_363745c4-873f-ad20-e063-6394a90a8a84
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Carlsbad Technology, Inc.
- Application
- ANDA075185
- Marketing category
- ANDA
- Marketing start
- 1998-11-13
- Substance
- DICLOFENAC SODIUM
- Active strength
- 25 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
| Rxcui | 855664, 855906, 855926 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61442-101-01 | Diclofenac SodiumDelayed Release | 100 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 100 | | 1 |
| 61442-101-01 | Diclofenac SodiumDelayed Release | 24 in 1 BOX | TABLET, DELAYED RELEASE | 24 | | 1 |
| 61442-101-10 | Diclofenac SodiumDelayed Release | 1000 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 1000 | | 1 |
| 61442-101-10 | Diclofenac SodiumDelayed Release | 12 in 1 BOX | TABLET, DELAYED RELEASE | 12 | | 1 |
| 61442-101-60 | Diclofenac SodiumDelayed Release | 24 in 1 BOX | TABLET, DELAYED RELEASE | 24 | | 1 |
| 61442-101-60 | Diclofenac SodiumDelayed Release | 60 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 60 | | 1 |
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 [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| DICLOFENAC | ACTIVE MOIETY | 144O8QL0L1 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | INACTIVE INGREDIENT | 74G4R6TH13 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| POLYETHYLENE GLYCOL 2000 | INACTIVE INGREDIENT | HAF0412YIT | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61442-101 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [CARLSBAD TECHNOLOGY, INC.] | 12 | Current NDC, Legacy NDC | 20240809_40879600-ba6c-43a8-aa5d-d0d41503d593.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 |
|---|
| 61442-101-01 | 61442010101 | 24 BOTTLE, PLASTIC in 1 BOX (61442-101-01) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | 1998-11-13 | 0000-00-00 | No | No | Current |
| 61442-101-10 | 61442010110 | 12 BOTTLE, PLASTIC in 1 BOX (61442-101-10) / 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | 1998-11-13 | 0000-00-00 | No | No | Current |
| 61442-101-60 | 61442010160 | 24 BOTTLE, PLASTIC in 1 BOX (61442-101-60) / 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | 1998-11-13 | 0000-00-00 | No | No | Current |