Diclofenac Sodium
- Product NDC
- 10544-189
- 11-digit product format
- 105440189
- Labeler code
- 10544
- Product ID
- 10544-189_df595412-7b9d-4fa2-a12d-e01f843abf4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA075185
- Marketing category
- ANDA
- Marketing start
- 2013-09-30
- Marketing end
- 0000-00-00
- Substance
- DICLOFENAC SODIUM
- Active strength
- 75 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 |
|---|
| 10544-189-01 | Diclofenac SodiumDelayed Release | 1000 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 1000 | | 4 |
| 10544-189-14 | Diclofenac SodiumDelayed Release | 14 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 14 | | 4 |
| 10544-189-20 | Diclofenac SodiumDelayed Release | 20 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 20 | | 4 |
| 10544-189-30 | Diclofenac SodiumDelayed Release | 30 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 30 | | 4 |
| 10544-189-60 | Diclofenac SodiumDelayed Release | 60 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 60 | | 4 |
| 10544-189-90 | Diclofenac SodiumDelayed Release | 90 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 90 | | 4 |
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 [BLENHEIM PHARMACAL, INC.] | 4 | |
| Diclofenac | ACTIVE MOIETY | 144O8QL0L1 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 4 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 4 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | INACTIVE INGREDIENT | 74G4R6TH13 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 4 | |
| POLYETHYLENE GLYCOL 2000 | INACTIVE INGREDIENT | HAF0412YIT | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 4 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 4 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-189 | DICLOFENAC SODIUM DELAYED RELEASE (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 4 | Legacy NDC, 6 package rows | 20140401_770b5db0-3565-409d-a274-caa132fb8d89.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-189-01 | 10544018901 | 1000 in 1 BOTTLE, PLASTIC | Historical |
| 10544-189-14 | 10544018914 | 14 in 1 BOTTLE, PLASTIC | Historical |
| 10544-189-20 | 10544018920 | 20 in 1 BOTTLE, PLASTIC | Historical |
| 10544-189-30 | 10544018930 | 30 in 1 BOTTLE, PLASTIC | Historical |
| 10544-189-60 | 10544018960 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 10544-189-90 | 10544018990 | 90 in 1 BOTTLE, PLASTIC | Historical |