Prescription drug · ANDA
Diclofenac Sodium Delayed Release NDC 63629-2013
diclofenac sodium · Diclofenac sodium 75 mg/1 · Tablet, Delayed release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2013-1 | 63629201301 | 24 BOTTLE, PLASTIC in 1 BOX (63629-2013-1) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTICMarketed from Nov 13, 1998 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 Delayed ReleaseSuffix: Delayed Release
- Generic name (nonproprietary)
- diclofenac sodium
- Active ingredients
- Diclofenac sodium — 75 mg/1
- Dosage form
- Tablet, Delayed release
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075185
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 63629-2013_ae287719-9402-4581-86ca-b017a1ad99c3SPL ID ae287719-9402-4581-86ca-b017a1ad99c3SPL set ID e6a1ff58-a541-46f8-9663-eed53b7cf392RxCUI 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
N463629201301followed by a unit qualifier and the quantityPackage 63629-2013-01. 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. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals ( see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac is 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.
Other NDCs under ANDA 075185
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 Delayed Releasediclofenac sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | REMEDYREPACK INC. | 70518-0756 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | Proficient Rx LP | 63187-222 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-967 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-968 |
| Diclofenac Sodium DRdiclofenac sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0189 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-0542 |
| Diclofenac Sodium DRdiclofenac sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0197 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-0543 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | A-S Medication Solutions | 50090-0545 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | Bryant Ranch Prepack | 71335-0357 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | REMEDYREPACK INC. | 70518-0627 |
| Diclofenac Sodium D/R | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | DirectRx | 72189-675 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | Carlsbad Technology, Inc. | 61442-102 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 25 mg/1 | Tablet, Delayed releaseOral | Carlsbad Technology, Inc. | 61442-101 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | Carlsbad Technology, Inc. | 61442-103 |
| Diclofenac Sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | AvKARE | 42291-231 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | NuCare Pharmaceuticals, Inc. | 68071-3184 |
| Diclofenac Sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | AvKARE | 42291-230 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 75 mg/1 | Tablet, Delayed releaseOral | PHOENIX RX LLC | 85509-1103 |
| Diclofenac Sodium Delayed Releasediclofenac sodium | Diclofenac sodium 50 mg/1 | Tablet, Delayed releaseOral | Carlsbad Technology, Inc. | 61442-226 |
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