Diclofenac Sodium
- Product NDC
- 68001-201
- 11-digit product format
- 680010201
- Labeler code
- 68001
- Product ID
- 68001-201_964b1f7e-8c60-4c05-8542-c987cee5ca5d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA074376
- Marketing category
- ANDA
- Marketing start
- 2014-02-24
- Marketing end
- 0000-00-00
- Substance
- DICLOFENAC SODIUM
- Active strength
- 50 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
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68001-201-00 | 2020-02-19 | C162847 | 48780-1 | 9d75b9cf-ed2f-f424-e053-dadaa90a57ce | cbdc93dd-860a-4bf7-b86f-5c9c9e2e553b |
| 68001-201-06 | 2020-02-19 | C162847 | 48780-1 | 9d75b9cf-ed2f-f424-e053-dadaa90a57ce | cbdc93dd-860a-4bf7-b86f-5c9c9e2e553b |
| 68001-201-08 | 2020-02-19 | C162847 | 48780-1 | 9d75b9cf-ed2f-f424-e053-dadaa90a57ce | cbdc93dd-860a-4bf7-b86f-5c9c9e2e553b |
| 68001-201-00 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-ed2f-f424-e053-dadaa90a57ce | cbdc93dd-860a-4bf7-b86f-5c9c9e2e553b |
| 68001-201-06 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-ed2f-f424-e053-dadaa90a57ce | cbdc93dd-860a-4bf7-b86f-5c9c9e2e553b |
| 68001-201-08 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-ed2f-f424-e053-dadaa90a57ce | cbdc93dd-860a-4bf7-b86f-5c9c9e2e553b |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68001-201-00 | EA - Each | 68001-201 | 438302f0-aed3-477d-88e5-66e1523bb59d | 1 | 2014-04-03 |
| 68001-201-06 | EA - Each | 68001-201 | 655bdda7-4853-47ec-aefe-2cd158caeb35 | 1 | 2014-04-03 |
| 68001-201-08 | EA - Each | 68001-201 | d1a68d87-2359-43bc-8670-cc590e3fd3a7 | 1 | 2014-04-03 |