Betamethasone Dipropionate

Product NDC
0472-0382
Requested package NDC
0472-0382-15
11-digit product format
004720382
Labeler code
0472
Product ID
0472-0382_dcf91aa2-eab5-405f-b2ed-647742457d9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
OINTMENT, AUGMENTED
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
ANDA074304
Marketing category
ANDA
Marketing start
1995-09-01
Substance
BETAMETHASONE DIPROPIONATE
Active strength
.5 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0472-03820472-0382-15DDiscontinued by firm2026-11-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A074304-001BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074304-001AB

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-31c2088c7a36db…
2026-09-14 22:38:342026-08A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-3184e616aacf4f…
2026-08-18 06:07:402026-07A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-313f01610625f2…
2019-09-15 20:21 UTC2019-09A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074304-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASEOINTMENT, AUGMENTED / TOPICALAB1995-08-313a93d1ddd44b…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A074304-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08A074304-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A074304-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074304-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074304-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074304-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074304-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074304-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074304-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074304-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074304-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074304-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074304-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074304-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074304-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074304-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074304-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074304-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074304-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074304-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074304-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074304-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074304-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074304-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074304-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074304-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074304-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074304-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074304-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074304-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074304-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074304-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074304-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074304-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074304-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074304-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074304-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074304-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074304-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074304-001AB13a93d1ddd44b…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Betamethasone Dipropionate
Listing expiration
2027-12-31

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
848180Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
af8317d7-b280-4f40-ad88-802f99d33d78Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0472-0382-15Betamethasone Dipropionate15 g in 1 TUBEOINTMENT, AUGMENTED1521
0472-0382-15Betamethasone Dipropionate1 in 1 CARTONOINTMENT, AUGMENTED121
0472-0382-45Betamethasone Dipropionate45 g in 1 TUBEOINTMENT, AUGMENTED4521
0472-0382-45Betamethasone Dipropionate1 in 1 CARTONOINTMENT, AUGMENTED121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0382-15GM - Gram0472-03823e51766a-38bb-4ea9-ad43-1c4f9bc96f3e12013-02-13
0472-0382-45GM - Gram0472-038219716fea-f3b5-473d-a633-39018b316f1212013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-0382BETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [ACTAVIS PHARMA, INC.]21Current NDC, Legacy NDC, 4 package rows20230621_af8317d7-b280-4f40-ad88-802f99d33d78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848180betamethasone dipropionate 0.05 % Augmented Topical OintmentPSNaf8317d7-b280-4f40-ad88-802f99d33d7821
848180Augmented betamethasone 0.0005 MG/MG Topical OintmentSCDaf8317d7-b280-4f40-ad88-802f99d33d7821
848180augmented betamethasone 0.05 % Topical OintmentSYaf8317d7-b280-4f40-ad88-802f99d33d7821
848180betamethasone 0.05 % Augmented Topical OintmentSYaf8317d7-b280-4f40-ad88-802f99d33d7821
848180betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Augmented Topical OintmentSYaf8317d7-b280-4f40-ad88-802f99d33d7821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-0382-15004720382151 TUBE in 1 CARTON (0472-0382-15) / 15 g in 1 TUBE1 tube1995-09-010000-00-00NoNoCurrent