Betamethasone Dipropionate

Product NDC
50090-0236
11-digit product format
500900236
Labeler code
50090
Product ID
50090-0236_7ec59c42-94e8-4831-8cc1-83d0a703f90b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
NDA019141
Marketing category
NDA
Marketing start
1984-09-04
Substance
BETAMETHASONE DIPROPIONATE
Active strength
.5 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
N019141-001BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019141-001AB

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 06:07:402026-07N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-0487673890dc5c…
2021-03-12 10:30 UTC2021-03N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-043f01610625f2…
2019-09-15 20:21 UTC2019-09N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-04b00525d2431f…
2019-07-19 19:46 UTC2019-07N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-043f0d92c62455…
2023-05-13 08:27 UTC2023-05N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-04053a50430f4f…
2023-01-26 05:58 UTC2023-01N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019141-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT / TOPICALABRLD, RS1984-09-04e64feba35796…

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 06:07:402026-07N019141-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019141-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019141-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019141-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019141-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019141-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019141-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019141-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019141-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019141-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019141-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019141-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019141-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019141-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019141-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019141-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019141-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019141-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019141-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019141-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019141-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019141-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N019141-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019141-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019141-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019141-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N019141-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N019141-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019141-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019141-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019141-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019141-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019141-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019141-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019141-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N019141-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N019141-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019141-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019141-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019141-001AB1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAMETHASONE DIPROPIONATE.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
826Y60901UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197405Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7da1c732-3477-4031-b776-149bd5ceea27Available 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
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0236-0Betamethasone Dipropionate1 in 1 CARTONOINTMENT124
50090-0236-0Betamethasone Dipropionate15 g in 1 TUBEOINTMENT1524

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0236-0GM - Gram50090-0236c257227f-3569-4a5a-b071-5d265cd2565012018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0236BETAMETHASONE DIPROPIONATE OINTMENT [A-S MEDICATION SOLUTIONS]24Current NDC, Legacy NDC, 2 package rows20230307_7da1c732-3477-4031-b776-149bd5ceea27.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC0173ed23-9f7c-466e-9eba-f6859d05f9872026-07-29Adverse reactionsExact identifier
application applno (NDA): 019141
application number: NDA019141
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEA-S Medication Solutions7da1c732-3477-4031-b776-149bd5ceea272023-03-06Adverse reactionsExact identifier
application applno (NDA): 019141
application number: NDA019141
ndc (product): 50090-0236

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197405betamethasone dipropionate 0.05 % Topical OintmentPSN7da1c732-3477-4031-b776-149bd5ceea2724
197405betamethasone 0.0005 MG/MG Topical OintmentSCD7da1c732-3477-4031-b776-149bd5ceea2724
197405betamethasone 0.05 % Topical OintmentSY7da1c732-3477-4031-b776-149bd5ceea2724
197405betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical OintmentSY7da1c732-3477-4031-b776-149bd5ceea2724

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0236-0500900236001 TUBE in 1 CARTON (50090-0236-0) / 15 g in 1 TUBE1 tube2016-06-290000-00-00NoNoCurrent