Diclofenac Sodium
- Product NDC
- 55289-150
- 11-digit product format
- 552890150
- Labeler code
- 55289
- Product ID
- 55289-150_3466672c-1212-3459-e063-6294a90a1288
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA074514
- Marketing category
- ANDA
- Marketing start
- 1996-03-26
- 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
- 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 |
|---|
| 55289-150-10 | Diclofenac Sodium | 10 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 10 | | 25 |
| 55289-150-15 | Diclofenac Sodium | 15 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 15 | | 25 |
| 55289-150-20 | Diclofenac Sodium | 20 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 20 | | 25 |
| 55289-150-28 | Diclofenac Sodium | 28 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 28 | | 25 |
| 55289-150-30 | Diclofenac Sodium | 30 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 30 | | 25 |
| 55289-150-60 | Diclofenac Sodium | 60 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 60 | | 25 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DICLOFENAC SODIUM | ACTIVE INGREDIENT | QTG126297Q | DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| DICLOFENAC | ACTIVE MOIETY | 144O8QL0L1 | DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| SODIUM ALGINATE | INACTIVE INGREDIENT | C269C4G2ZQ | DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | DICLOFENAC SODIUM (DICLOFENAC SODIUM) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55289-150 | DICLOFENAC SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 25 | Current NDC, Legacy NDC, 6 package rows | 20250507_87d5a720-f154-4c4b-b2d4-0ae58455dda0.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 |
|---|
| 55289-150-10 | 55289015010 | 10 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-10) | 2011-03-31 | 0000-00-00 | No | No | Current |
| 55289-150-15 | 55289015015 | 15 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-15) | 2011-03-31 | 0000-00-00 | No | No | Current |
| 55289-150-20 | 55289015020 | 20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-20) | 2011-03-31 | 0000-00-00 | No | No | Current |
| 55289-150-28 | 55289015028 | 28 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-28) | 2011-03-31 | 0000-00-00 | No | No | Current |
| 55289-150-30 | 55289015030 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-30) | 2011-03-31 | 0000-00-00 | No | No | Current |
| 55289-150-60 | 55289015060 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-60) | 2011-03-31 | 0000-00-00 | No | No | Current |