Betamethasone Valerate
- Product NDC
- 0168-0033
- 11-digit product format
- 001680033
- Labeler code
- 0168
- Product ID
- 0168-0033_41e96a74-4120-436e-97e5-2dc62af84b2a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- betamethasone valerate
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
- Application
- NDA018865
- Marketing category
- NDA
- Marketing start
- 1983-08-31
- Substance
- BETAMETHASONE VALERATE
- Active strength
- 1 mg/g
- 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 Valerate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BETAMETHASONE VALERATE | 1 mg/g |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 9IFA5XM7R2 |
| Rxcui | 197407, 197408, 197409 |
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 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0168-0033-15 | Betamethasone Valerate | 15 g in 1 TUBE | OINTMENT | 15 | 10 | |
| 0168-0033-46 | Betamethasone Valerate | 45 g in 1 TUBE | OINTMENT | 45 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0168-0033-15 | GM - Gram | 0168-0033 | a42239e9-0c73-4dbd-a2db-95d5ff6a1e33 | 1 | 2013-03-03 |
| 0168-0033-46 | GM - Gram | 0168-0033 | 07944208-5f7c-47f6-ba1f-3bfcbf26cf0f | 1 | 2013-03-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0168-0033 | BETAMETHASONE VALERATE CREAM BETAMETHASONE VALERATE OINTMENT BETAMETHASONE VALERATE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20220112_0b386ccc-a2d4-4d18-a2d7-e46ff894c674.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197407 | betamethasone 0.1 % Topical Cream | PSN | 0b386ccc-a2d4-4d18-a2d7-e46ff894c674 | 10 |
| 197408 | betamethasone valerate 0.1 % Topical Lotion | PSN | 0b386ccc-a2d4-4d18-a2d7-e46ff894c674 | 10 |
| 197409 | betamethasone valerate 0.1 % Topical Ointment | PSN | 0b386ccc-a2d4-4d18-a2d7-e46ff894c674 | 10 |
| 197409 | betamethasone 0.001 MG/MG Topical Ointment | SCD | 0b386ccc-a2d4-4d18-a2d7-e46ff894c674 | 10 |
| 197407 | betamethasone 1 MG/ML Topical Cream | SCD | 0b386ccc-a2d4-4d18-a2d7-e46ff894c674 | 10 |
| 197408 | betamethasone 1 MG/ML Topical Lotion | SCD | 0b386ccc-a2d4-4d18-a2d7-e46ff894c674 | 10 |
| 197407 | betamethasone 0.1 % Topical Cream | SY | 0b386ccc-a2d4-4d18-a2d7-e46ff894c674 | 10 |
| 197408 | betamethasone 0.1 % Topical Lotion | SY | 0b386ccc-a2d4-4d18-a2d7-e46ff894c674 | 10 |
| 197409 | betamethasone 0.1 % Topical Ointment | SY | 0b386ccc-a2d4-4d18-a2d7-e46ff894c674 | 10 |
| 197409 | betamethasone 1 MG/GM (as betamethasone valerate 1.2 MG/GM) Topical Ointment | SY | 0b386ccc-a2d4-4d18-a2d7-e46ff894c674 | 10 |
| 197407 | betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical Cream | SY | 0b386ccc-a2d4-4d18-a2d7-e46ff894c674 | 10 |
| 197408 | betamethasone 1 MG/ML (betamethasone valerate 1.2 MG/ML) Topical Lotion | SY | 0b386ccc-a2d4-4d18-a2d7-e46ff894c674 | 10 |
| 197409 | betamethasone valerate 0.1 % Topical Ointment | PSN | 50d4763d-5a84-4c45-be06-040c4a527470 | 5 |
| 197409 | betamethasone 0.001 MG/MG Topical Ointment | SCD | 50d4763d-5a84-4c45-be06-040c4a527470 | 5 |
| 197409 | betamethasone 0.1 % Topical Ointment | SY | 50d4763d-5a84-4c45-be06-040c4a527470 | 5 |
| 197409 | betamethasone 1 MG/GM (as betamethasone valerate 1.2 MG/GM) Topical Ointment | SY | 50d4763d-5a84-4c45-be06-040c4a527470 | 5 |
| 197407 | betamethasone 0.1 % Topical Cream | PSN | 72bcd320-39d6-49db-bc7b-d140d200076a | 1 |
| 197408 | betamethasone valerate 0.1 % Topical Lotion | PSN | 72bcd320-39d6-49db-bc7b-d140d200076a | 1 |
| 197409 | betamethasone valerate 0.1 % Topical Ointment | PSN | 72bcd320-39d6-49db-bc7b-d140d200076a | 1 |
| 197409 | betamethasone valerate 0.1 % Topical Ointment | PSN | eeb337ba-0d7e-42cd-840a-78783b5688d7 | 1 |
| 197409 | betamethasone 0.001 MG/MG Topical Ointment | SCD | 72bcd320-39d6-49db-bc7b-d140d200076a | 1 |
| 197409 | betamethasone 0.001 MG/MG Topical Ointment | SCD | eeb337ba-0d7e-42cd-840a-78783b5688d7 | 1 |
| 197407 | betamethasone 1 MG/ML Topical Cream | SCD | 72bcd320-39d6-49db-bc7b-d140d200076a | 1 |
| 197408 | betamethasone 1 MG/ML Topical Lotion | SCD | 72bcd320-39d6-49db-bc7b-d140d200076a | 1 |
| 197407 | betamethasone 0.1 % Topical Cream | SY | 72bcd320-39d6-49db-bc7b-d140d200076a | 1 |
| 197408 | betamethasone 0.1 % Topical Lotion | SY | 72bcd320-39d6-49db-bc7b-d140d200076a | 1 |
| 197409 | betamethasone 0.1 % Topical Ointment | SY | 72bcd320-39d6-49db-bc7b-d140d200076a | 1 |
| 197409 | betamethasone 0.1 % Topical Ointment | SY | eeb337ba-0d7e-42cd-840a-78783b5688d7 | 1 |
| 197409 | betamethasone 1 MG/GM (as betamethasone valerate 1.2 MG/GM) Topical Ointment | SY | 72bcd320-39d6-49db-bc7b-d140d200076a | 1 |
| 197409 | betamethasone 1 MG/GM (as betamethasone valerate 1.2 MG/GM) Topical Ointment | SY | eeb337ba-0d7e-42cd-840a-78783b5688d7 | 1 |
| 197407 | betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical Cream | SY | 72bcd320-39d6-49db-bc7b-d140d200076a | 1 |
| 197408 | betamethasone 1 MG/ML (betamethasone valerate 1.2 MG/ML) Topical Lotion | SY | 72bcd320-39d6-49db-bc7b-d140d200076a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0168-0033-15 | 00168003315 | 15 g in 1 TUBE (0168-0033-15) | 15 g | 1983-08-31 | 0000-00-00 | No | No | Current |
| 0168-0033-46 | 00168003346 | 45 g in 1 TUBE (0168-0033-46) | 45 g | 1983-08-31 | 0000-00-00 | No | No | Current |