Prescription drug · ANDA
Diclofenac Sodium NDC 60429-422
Diclofenac sodium 75 mg/1 · Tablet, Delayed release · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60429-422-01 | 6042904220160429042201 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (60429-422-01)Marketed from Jul 27, 2015 | |
| 60429-422-10 | 6042904221060429042210 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (60429-422-10)Marketed from Jul 27, 2015 | |
| 60429-422-18 | 6042904221860429042218 | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (60429-422-18)Marketed from Jul 27, 2015 | |
| 60429-422-60 | 6042904226060429042260 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (60429-422-60)Marketed from Jul 27, 2015 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Diclofenac Sodium
- Generic name (nonproprietary)
- diclofenac sodium
- Active ingredients
- Diclofenac sodium — 75 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Golden State Medical Supply, Inc.NDC labeler code 60429
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074514
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 60429-422_52d448a2-01fb-19f8-e063-6294a90ab893SPL ID 52d448a2-01fb-19f8-e063-6294a90ab893SPL set ID c1d87003-f54b-4381-9e11-1c39ea2d9eb3RxCUI 855906, 855926UNII QTG126297Q
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N460429042201followed by a unit qualifier and the quantityPackage 60429-0422-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ) . Diclofenac sodium delayed-release tablets are indicated: for relief of the signs and symptoms of osteoarthritis for relief of the signs and symptoms of rheumatoid arthritis for acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
Excerpt only. Read the full label for complete information.
About NDC 60429-422
- What is NDC 60429-422?
- 60429-422 is the product NDC for Diclofenac Sodium, Diclofenac sodium 75 mg/1 tablet, delayed release, listed with the FDA by Golden State Medical Supply, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diclofenac Sodium.
- What is the active ingredient?
- Diclofenac sodium.
- Who is the labeler?
- Golden State Medical Supply, Inc., NDC labeler code 60429. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diclofenac Sodium?
- 241 other product NDCs are listed under this name. See all Diclofenac Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diclofenac Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diclofenac Sodiumdiclofenac sodium topical gel, 1% | Diclofenac sodium 10 mg/g | GelTopical | IPG Pharmaceuticals, inc. | 71085-084 | 71085-0084-03 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Target Corporation | 11673-028 | 11673-0028-1011673-0028-15 |
| Diclofenac Sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | Northwind Health Company, LLC | 82868-114 | 82868-0114-30 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Preferred Pharmaceuticals Inc. | 68788-4135 | 68788-4135-01 |
| Diclofenac Sodium | Diclofenac sodium 100 mg/1 | Tablet, Film coated, Extended releaseOral | Aurobindo Pharma Limited | 84386-103 | 84386-0103-01 |
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | REMEDYREPACK INC. | 70518-4694 | 70518-4694-00 |
| Diclofenac sodium | Diclofenac sodium 30 mg/g | GelTopical | Preferred Pharmaceuticals Inc. | 68788-4118 | 68788-4118-01 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Preferred Pharmaceuticals Inc. | 68788-4335 | 68788-4335-01 |
| Diclofenac Sodium | Diclofenac sodium 25 mg/1 | Tablet, Delayed releaseOral | Umedica Laboratories USA Inc. | 60290-082 | 60290-0082-01 |
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | Umedica Laboratories USA Inc. | 60290-083 | 60290-0083-0160290-0083-0260290-0083-03+1 more |
Other NDCs under ANDA 074514
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | Actavis Pharma, Inc. | 0228-2550 |
| Diclofenac Sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | Actavis Pharma, Inc. | 0228-2551 |
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | PD-Rx Pharmaceuticals, Inc. | 43063-467 |
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-0538 |
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-0539 |
| Diclofenac Sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | PD-Rx Pharmaceuticals, Inc. | 55289-150 |
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | Golden State Medical Supply, Inc. | 60429-421 |
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 63187-522 |
| Diclofenac Sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 63187-761 |
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-068 |