Betamethasone Valerate
- Product NDC
- 21695-584
- 11-digit product format
- 216950584
- Labeler code
- 21695
- Product ID
- 21695-584_f242cdf5-6921-431f-8add-4d17887ebc93
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Betamethasone Valerate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Rebel Distributors Corp.
- Application
- ANDA070062
- Marketing category
- ANDA
- Marketing start
- 1985-05-14
- Marketing end
- 0000-00-00
- Substance
- BETAMETHASONE VALERATE
- Active strength
- 1 mg/g
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dde7b902-54a1-627e-12f1-9e6d244ab88c | Product name | 4 | 20250317 |
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 69b49899-11cf-4f7e-bd0a-7dc93b27311b | Product name | 3 | 20250130 |
| bbdc14c7-d940-43b5-a2f7-36c425991f3c | Product name | 1 | 20240320 |
| 0a2fcc35-464b-9ec2-a622-753662cdd48c | Product name | 3 | 20240216 |
| 6f762601-17ef-4321-8f47-77783d3c4d8b | Product name | 3 | 20231116 |
| 1dbefad7-ab34-69c3-e51a-e7148aa38f70 | Product name | 5 | 20220921 |
| 7fea2046-07a9-4bb6-9409-828ac6f1f6df | Product name | 1 | 20210201 |
| f059f1a2-0e64-4839-9a7f-42687c91a44b | Product name | 1 | 20201007 |
| 4ea9e4b5-b452-48ad-9b25-b9a4d403405d | Product name | 1 | 20160310 |
| f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6 | Product name | 2 | 20151106 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
| 4f07db9b-3707-3e2c-05b5-d7852ba808c4 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-584-15 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4c50-48b1-e053-8cdaa90a720a | Betamethasone Valerate Cream USP, 0.1% |
| 21695-584-45 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4c50-48b1-e053-8cdaa90a720a | Betamethasone Valerate Cream USP, 0.1% |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-584-15 | Betamethasone Valerate | 1 in 1 CARTON | CREAM | 1 | 1 | |
| 21695-584-15 | Betamethasone Valerate | 15 g in 1 TUBE | CREAM | 15 | 1 | |
| 21695-584-45 | Betamethasone Valerate | 45 g in 1 TUBE | CREAM | 45 | 1 | |
| 21695-584-45 | Betamethasone Valerate | 1 in 1 CARTON | CREAM | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-584-15 | GM - Gram | 21695-584 | e27ebeca-55c8-4475-a8b2-d6870d063f7d | 1 | 2012-07-24 |
| 21695-584-45 | GM - Gram | 21695-584 | 523a4d1e-31db-418d-9e10-5797a62a3bd8 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197407 | betamethasone 0.1 % Topical Cream | PSN | f242cdf5-6921-431f-8add-4d17887ebc93 | 1 |
| 197407 | betamethasone 1 MG/ML Topical Cream | SCD | f242cdf5-6921-431f-8add-4d17887ebc93 | 1 |
| 197407 | betamethasone 0.1 % Topical Cream | SY | f242cdf5-6921-431f-8add-4d17887ebc93 | 1 |
| 197407 | betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical Cream | SY | f242cdf5-6921-431f-8add-4d17887ebc93 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 21695-584-15 | 21695058415 | 1 in 1 CARTON | Historical | |
| 21695-584-45 | 21695058445 | 45 g in 1 TUBE | 45 g | Historical |