Betamethasone Dipropionate
- Product NDC
- 0168-0265
- 11-digit product format
- 001680265
- Labeler code
- 0168
- Product ID
- 0168-0265_98a5f88e-6ba5-4064-b851-17b63a13e883
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Betamethasone dipropionate
- Dosage form
- CREAM, AUGMENTED
- Route
- TOPICAL
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
- Application
- ANDA076215
- Marketing category
- ANDA
- Marketing start
- 2003-12-09
- Marketing end
- 0000-00-00
- Substance
- BETAMETHASONE DIPROPIONATE
- Active strength
- 1 mg/g
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0168-0265-15 | 2020-12-07 | C162847 | 48780-1 | ab0e2407-35ae-f274-e053-dbdaa90a6471 | 07ffc9d3-85d3-4ac6-b1b5-d2d688389b89 |
| 0168-0265-50 | 2020-12-07 | C162847 | 48780-1 | ab0e2407-35ae-f274-e053-dbdaa90a6471 | 07ffc9d3-85d3-4ac6-b1b5-d2d688389b89 |
| 0168-0265-15 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-35ae-f274-e053-dbdaa90a6471 | 07ffc9d3-85d3-4ac6-b1b5-d2d688389b89 |
| 0168-0265-50 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-35ae-f274-e053-dbdaa90a6471 | 07ffc9d3-85d3-4ac6-b1b5-d2d688389b89 |
| 0168-0265-15 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-35ae-f274-e053-dbdaa90a6471 | 07ffc9d3-85d3-4ac6-b1b5-d2d688389b89 |
| 0168-0265-50 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-35ae-f274-e053-dbdaa90a6471 | 07ffc9d3-85d3-4ac6-b1b5-d2d688389b89 |
| 0168-0265-15 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-35ae-f274-e053-dbdaa90a6471 | 07ffc9d3-85d3-4ac6-b1b5-d2d688389b89 |
| 0168-0265-50 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-35ae-f274-e053-dbdaa90a6471 | 07ffc9d3-85d3-4ac6-b1b5-d2d688389b89 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0168-0265-15 | GM - Gram | 0168-0265 | dd1b5e6a-735e-4e5d-ae16-3667b06b3dce | 1 | 2012-07-24 |
| 0168-0265-50 | GM - Gram | 0168-0265 | 4db48579-957b-42d4-a1d0-9027ddc15684 | 1 | 2012-07-24 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0168-0265-15 | 00168026515 | 15 g in 1 TUBE (0168-0265-15) | 15 g | 2003-12-09 | 0000-00-00 | No | No | Current |
| 0168-0265-50 | 00168026550 | 50 g in 1 TUBE (0168-0265-50) | 50 g | 2003-12-09 | 0000-00-00 | No | No | Current |