Betamethasone Valerate

Product NDC
71205-040
11-digit product format
712050040
Labeler code
71205
Product ID
71205-040_dd1d8198-23a2-41d0-8462-6eb7c7eb53aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
betamethasone valerate
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
NDA018861
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018861-001BETAMETHASONE VALERATEBETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N018861-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-3187673890dc5c…
2021-03-12 10:30 UTC2021-03N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-313f01610625f2…
2019-09-15 20:21 UTC2019-09N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-31b00525d2431f…
2019-07-19 19:46 UTC2019-07N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-313f0d92c62455…
2023-05-13 08:27 UTC2023-05N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-31053a50430f4f…
2023-01-26 05:58 UTC2023-01N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018861-001BETAMETHASONE VALERATEEQ 0.1% BASECREAM / TOPICALABRLD, RS1983-08-31e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N018861-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018861-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018861-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018861-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018861-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018861-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018861-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018861-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018861-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018861-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018861-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018861-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018861-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018861-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018861-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018861-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018861-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018861-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018861-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018861-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018861-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018861-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N018861-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018861-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018861-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018861-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N018861-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018861-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018861-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018861-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018861-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018861-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018861-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018861-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018861-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018861-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018861-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018861-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018861-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018861-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Betamethasone Valerate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAMETHASONE VALERATE1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9IFA5XM7R2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197407Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
036706f1-0a24-4765-9a62-820ad64934beAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-040-15Betamethasone Valerate15 g in 1 TUBECREAM155

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-040-15GM - Gram71205-040fcb4d806-1ba5-4423-a6d9-c803fa31408112018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-040BETAMETHASONE VALERATE CREAM [PROFICIENT RX LP]5Current NDC, Legacy NDC, 1 package rows20220702_036706f1-0a24-4765-9a62-820ad64934be.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Betamethasone ValerateBETAMETHASONE VALERATEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC0b386ccc-a2d4-4d18-a2d7-e46ff894c6742026-01-28Adverse reactionsExact identifier
application applno (NDA): 018861
application number: NDA018861
Betamethasone ValerateBETAMETHASONE VALERATEPreferred Pharmaceuticals Inc.985d1f62-4bff-4bf1-b7c7-96cb456ef83d2025-02-07Adverse reactionsExact identifier
application applno (NDA): 018861
application number: NDA018861
Betamethasone ValerateBETAMETHASONE VALERATEProficient Rx LP036706f1-0a24-4765-9a62-820ad64934be2022-06-01Adverse reactionsExact identifier
application applno (NDA): 018861
application number: NDA018861
ndc (product): 71205-040

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197407betamethasone 0.1 % Topical CreamPSN036706f1-0a24-4765-9a62-820ad64934be5
197407betamethasone 1 MG/ML Topical CreamSCD036706f1-0a24-4765-9a62-820ad64934be5
197407betamethasone 0.1 % Topical CreamSY036706f1-0a24-4765-9a62-820ad64934be5
197407betamethasone 1 MG/ML (as betamethasone valerate 1.2 MG/ML) Topical CreamSY036706f1-0a24-4765-9a62-820ad64934be5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-040-157120500401515 g in 1 TUBE (71205-040-15) 15 g2018-05-010000-00-00NoNoCurrent