Diclofenac Sodium
- Product NDC
- 10544-933
- 11-digit product format
- 105440933
- Labeler code
- 10544
- Product ID
- 10544-933_1ed81758-3e5f-46d2-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA077863
- Marketing category
- ANDA
- Marketing start
- 2008-08-19
- 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 |
|---|
| 10544-933-14 | Diclofenac Sodium | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | | 2 |
| 10544-933-30 | Diclofenac Sodium | 30 in 1 BOTTLE | TABLET, DELAYED RELEASE | 30 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DICLOFENAC SODIUM | ACTIVE INGREDIENT | QTG126297Q | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| DICLOFENAC | ACTIVE MOIETY | 144O8QL0L1 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-933 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.] | 2 | Legacy NDC, 2 package rows | 20150903_1b52cd67-bbc7-251f-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-933-14 | 10544093314 | 14 in 1 BOTTLE | Historical |
| 10544-933-30 | 10544093330 | 30 in 1 BOTTLE | Historical |