Betamethasone Dipropionate

Product NDC
51672-1340
11-digit product format
516721340
Labeler code
51672
Product ID
51672-1340_3961e128-73c9-c458-e063-6294a90a8a8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
LOTION, AUGMENTED
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077477
Marketing category
ANDA
Marketing start
2007-05-21
Substance
BETAMETHASONE DIPROPIONATE
Active strength
.5 mg/mL
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
A077477-001BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077477-001AB

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 06:07:402026-07A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-213f01610625f2…
2019-09-15 20:21 UTC2019-09A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077477-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASELOTION, AUGMENTED / TOPICALABRS2007-05-21e64feba35796…

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 06:07:402026-07A077477-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077477-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077477-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077477-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077477-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077477-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077477-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077477-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077477-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077477-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077477-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077477-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077477-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077477-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077477-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077477-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077477-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077477-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077477-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077477-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077477-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077477-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A077477-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077477-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077477-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077477-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077477-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077477-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077477-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077477-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077477-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077477-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077477-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077477-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077477-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077477-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077477-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077477-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077477-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077477-001AB1e64feba35796…

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/mL

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
848178Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3b23a3c0-3306-4a2d-932d-25916d16dc68Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1340-3Betamethasone Dipropionate30 mL in 1 BOTTLELOTION, AUGMENTED308
51672-1340-3Betamethasone Dipropionate1 in 1 CARTONLOTION, AUGMENTED18
51672-1340-4Betamethasone Dipropionate1 in 1 CARTONLOTION, AUGMENTED18
51672-1340-4Betamethasone Dipropionate60 mL in 1 BOTTLELOTION, AUGMENTED608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1340-3ML - Milliliter51672-1340cc487549-b095-4df9-8679-b1a16e572c0112012-07-24
51672-1340-4ML - Milliliter51672-13400bfdc60b-602a-4151-813f-5fdb3d8b305d12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1340BETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [TARO PHARMACEUTICALS U.S.A., INC.]7Current NDC, Legacy NDC, 4 package rows20241222_3b23a3c0-3306-4a2d-932d-25916d16dc68.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Betamethasone DipropionateBETAMETHASONE DIPROPIONATESun Pharmaceutical Industries, Inc.3b23a3c0-3306-4a2d-932d-25916d16dc682025-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077477
application number: ANDA077477
ndc (product): 51672-1340

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848178betamethasone 0.05 % (betamethasone diproprionate 0.64 MG/ML) Augmented Topical LotionPSN3b23a3c0-3306-4a2d-932d-25916d16dc688
848178Augmented betamethasone 0.5 MG/ML Topical LotionSCD3b23a3c0-3306-4a2d-932d-25916d16dc688
848178augmented betamethasone 0.05 % Topical LotionSY3b23a3c0-3306-4a2d-932d-25916d16dc688
848178betamethasone 0.05 % (betamethasone diproprionate 0.64 MG/ML) Augmented Topical LotionSY3b23a3c0-3306-4a2d-932d-25916d16dc688

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1340-3516721340031 BOTTLE in 1 CARTON (51672-1340-3) / 30 mL in 1 BOTTLE1 bottle2007-05-210000-00-00NoNoCurrent
51672-1340-4516721340041 BOTTLE in 1 CARTON (51672-1340-4) / 60 mL in 1 BOTTLE1 bottle2007-05-210000-00-00NoNoCurrent