Betamethasone Dipropionate
- Product NDC
- 0168-0057
- 11-digit product format
- 001680057
- Labeler code
- 0168
- Product ID
- 0168-0057_3a499a57-9faa-419d-beeb-3aba6b8c2d7c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Betamethasone Dipropionate
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- Application
- ANDA070275
- Marketing category
- ANDA
- Marketing start
- 1985-08-12
- Substance
- BETAMETHASONE DIPROPIONATE
- Active strength
- .5 mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Betamethasone Dipropionate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BETAMETHASONE DIPROPIONATE | .5 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 826Y60901U |
| Rxcui | 197405, 238920, 240209 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dde7b902-54a1-627e-12f1-9e6d244ab88c | Product name | 4 | 20250317 |
| 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 |
| 4f07db9b-3707-3e2c-05b5-d7852ba808c4 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0168-0057-60 | Betamethasone Dipropionate | 1 in 1 CARTON | LOTION | 1 | 12 | |
| 0168-0057-60 | Betamethasone Dipropionate | 60 mL in 1 BOTTLE | LOTION | 60 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0168-0057-60 | ML - Milliliter | 0168-0057 | 1ab44197-ce71-4068-9d4f-93ad217e0d6c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0168-0057 | BETAMETHASONE DIPROPIONATE CREAM BETAMETHASONE DIPROPIONATE OINTMENT BETAMETHASONE DIPROPIONATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20220202_97dde5f5-a865-4af2-b562-8da72c8475f3.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 238920 | betamethasone 0.05 % Topical Cream | PSN | 97dde5f5-a865-4af2-b562-8da72c8475f3 | 12 |
| 240209 | betamethasone dipropionate 0.05 % Topical Lotion | PSN | 97dde5f5-a865-4af2-b562-8da72c8475f3 | 12 |
| 197405 | betamethasone dipropionate 0.05 % Topical Ointment | PSN | 97dde5f5-a865-4af2-b562-8da72c8475f3 | 12 |
| 197405 | betamethasone 0.0005 MG/MG Topical Ointment | SCD | 97dde5f5-a865-4af2-b562-8da72c8475f3 | 12 |
| 238920 | betamethasone 0.5 MG/ML Topical Cream | SCD | 97dde5f5-a865-4af2-b562-8da72c8475f3 | 12 |
| 240209 | betamethasone 0.5 MG/ML Topical Lotion | SCD | 97dde5f5-a865-4af2-b562-8da72c8475f3 | 12 |
| 238920 | betamethasone 0.05 % Topical Cream | SY | 97dde5f5-a865-4af2-b562-8da72c8475f3 | 12 |
| 240209 | betamethasone 0.05 % Topical Lotion | SY | 97dde5f5-a865-4af2-b562-8da72c8475f3 | 12 |
| 197405 | betamethasone 0.05 % Topical Ointment | SY | 97dde5f5-a865-4af2-b562-8da72c8475f3 | 12 |
| 238920 | betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical Cream | SY | 97dde5f5-a865-4af2-b562-8da72c8475f3 | 12 |
| 197405 | betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical Ointment | SY | 97dde5f5-a865-4af2-b562-8da72c8475f3 | 12 |
| 240209 | betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) Topical Lotion | SY | 97dde5f5-a865-4af2-b562-8da72c8475f3 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0168-0057-60 | 00168005760 | 1 BOTTLE in 1 CARTON (0168-0057-60) / 60 mL in 1 BOTTLE | 1 bottle | 1985-08-12 | 0000-00-00 | No | No | Current |