Veregen
- Product NDC
- 10337-450
- 11-digit product format
- 103370450
- Labeler code
- 10337
- Product ID
- 10337-450_e25d94c3-0838-41c0-92cb-ec04bf8165b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sinecatechins
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- PharmaDerm a division of Fougera Pharmaceuticals Inc.
- Application
- NDA021902
- Marketing category
- NDA
- Marketing start
- 2007-12-14
- Marketing end
- 2024-11-29
- Substance
- SINECATECHINS
- Active strength
- 150 mg/g
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10337-450-03 | 2020-08-25 | C162847 | 48780-1 | ab0e2407-2b06-f274-e053-dbdaa90a6471 | 2c1cd745-79ab-487d-b759-995794cedb92 |
| 10337-450-08 | 2020-08-25 | C162847 | 48780-1 | ab0e2407-2b06-f274-e053-dbdaa90a6471 | 2c1cd745-79ab-487d-b759-995794cedb92 |
| 10337-450-15 | 2020-08-25 | C162847 | 48780-1 | ab0e2407-2b06-f274-e053-dbdaa90a6471 | 2c1cd745-79ab-487d-b759-995794cedb92 |
| 10337-450-99 | 2020-08-25 | C162847 | 48780-1 | ab0e2407-2b06-f274-e053-dbdaa90a6471 | 2c1cd745-79ab-487d-b759-995794cedb92 |
| 10337-450-03 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2b06-f274-e053-dbdaa90a6471 | 2c1cd745-79ab-487d-b759-995794cedb92 |
| 10337-450-08 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2b06-f274-e053-dbdaa90a6471 | 2c1cd745-79ab-487d-b759-995794cedb92 |
| 10337-450-15 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2b06-f274-e053-dbdaa90a6471 | 2c1cd745-79ab-487d-b759-995794cedb92 |
| 10337-450-99 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2b06-f274-e053-dbdaa90a6471 | 2c1cd745-79ab-487d-b759-995794cedb92 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10337-450-03 | GM - Gram | 10337-450 | 27c97b44-2945-498e-b1cf-76c5a97859ff | 1 | 2013-02-13 |
| 10337-450-15 | GM - Gram | 10337-450 | 14fd44a0-217e-4f9a-8735-c73b40089d67 | 1 | 2012-07-24 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 10337-450-03 | 10337045003 | 1 TUBE in 1 CARTON (10337-450-03) > 30 g in 1 TUBE | 1 tube | 2007-12-14 | 0000-00-00 | No | No | Current |
| 10337-450-08 | 10337045008 | 1 TUBE in 1 CARTON (10337-450-08) > 2 g in 1 TUBE | 1 tube | 2007-12-14 | 0000-00-00 | No | No | Current |
| 10337-450-15 | 10337045015 | 1 TUBE in 1 CARTON (10337-450-15) > 15 g in 1 TUBE | 1 tube | 2007-12-14 | 0000-00-00 | No | No | Current |
| 10337-450-99 | 10337045099 | 1 TUBE in 1 CARTON (10337-450-99) > 4 g in 1 TUBE | 1 tube | 2007-12-14 | 0000-00-00 | No | No | Current |