Betamethasone Dipropionate

Product NDC
51672-1274
Requested package NDC
51672-1274-6
11-digit product format
516721274
Labeler code
51672
Product ID
51672-1274_38f55e1e-dffd-ee76-e063-6394a90aee5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA073552
Marketing category
ANDA
Marketing start
1992-04-30
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 1.

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
A073552-001BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A073552-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-303f01610625f2…
2019-09-15 20:21 UTC2019-09A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A073552-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB1992-04-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A073552-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073552-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A073552-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073552-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073552-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073552-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073552-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073552-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073552-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073552-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073552-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073552-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073552-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073552-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073552-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073552-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073552-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073552-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073552-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073552-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A073552-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A073552-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A073552-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A073552-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A073552-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A073552-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A073552-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A073552-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A073552-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A073552-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A073552-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A073552-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A073552-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A073552-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A073552-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A073552-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A073552-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A073552-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A073552-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A073552-001AB1cb3db0bc1861…

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
238920Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bc12c828-54ba-411d-b752-9b735f7adf63Available 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
51672-1274-1Betamethasone Dipropionate15 g in 1 TUBECREAM157
51672-1274-1Betamethasone Dipropionate1 in 1 CARTONCREAM17
51672-1274-6Betamethasone Dipropionate1 in 1 CARTONCREAM17
51672-1274-6Betamethasone Dipropionate45 g in 1 TUBECREAM457

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1274-1GM - Gram51672-127496629d41-03df-48dc-8a6e-779d839e010712012-07-24
51672-1274-6GM - Gram51672-1274fc92771e-edb4-4374-aac8-0e44502979c612012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1274BETAMETHASONE DIPROPIONATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]6Current NDC, Legacy NDC, 4 package rows20241222_bc12c828-54ba-411d-b752-9b735f7adf63.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 DipropionateBETAMETHASONE DIPROPIONATEGolden State Medical Supply, Inc.9571a031-179d-7dfb-e053-2995a90aa0162025-07-10Adverse reactionsExact identifier
application applno (ANDA): 073552
application number: ANDA073552
Betamethasone DipropionateBETAMETHASONE DIPROPIONATESun Pharmaceutical Industries, Inc.bc12c828-54ba-411d-b752-9b735f7adf632025-07-02Adverse reactionsExact identifier
application applno (ANDA): 073552
application number: ANDA073552
ndc (package): 51672-1274-6
ndc (product): 51672-1274
ndc11 (package): 51672127406
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEA-S Medication Solutions5137f94e-6818-440b-a33e-228aa27de61d2024-07-30Adverse reactionsExact identifier
application applno (ANDA): 073552
application number: ANDA073552

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238920betamethasone 0.05 % Topical CreamPSN5137f94e-6818-440b-a33e-228aa27de61d8
238920betamethasone 0.5 MG/ML Topical CreamSCD5137f94e-6818-440b-a33e-228aa27de61d8
238920betamethasone 0.05 % Topical CreamSY5137f94e-6818-440b-a33e-228aa27de61d8
238920betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical CreamSY5137f94e-6818-440b-a33e-228aa27de61d8
238920betamethasone 0.05 % Topical CreamPSNbc12c828-54ba-411d-b752-9b735f7adf637
238920betamethasone 0.5 MG/ML Topical CreamSCDbc12c828-54ba-411d-b752-9b735f7adf637
238920betamethasone 0.05 % Topical CreamSYbc12c828-54ba-411d-b752-9b735f7adf637
238920betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical CreamSYbc12c828-54ba-411d-b752-9b735f7adf637

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1274-6516721274061 TUBE in 1 CARTON (51672-1274-6) / 45 g in 1 TUBE1 tube1992-04-300000-00-00NoNoCurrent