FDA.reportPublic FDA data

BETAMETHASONE DIPROPIONATE

Product NDC
59651-891
11-digit product format
596510891
Labeler code
59651
Product ID
59651-891_24ff4493-605d-4d40-b904-ccbed6651880
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BETAMETHASONE DIPROPIONATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Aurobindo Pharma Limited
Application
ANDA219348
Marketing category
ANDA
Marketing start
2026-01-26
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

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
A219348-001BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2026-01-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219348-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A219348-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2026-01-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219348-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2026-01-26011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219348-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM / TOPICALAB2026-01-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A219348-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219348-001AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219348-001AB1a50c72e98297…

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
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
a4f8db3a-0aed-451c-98ba-c4ce37656792Available 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
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
59651-891-14BETAMETHASONE DIPROPIONATE1 in 1 CARTONCREAM12
59651-891-14BETAMETHASONE DIPROPIONATE15 g in 1 TUBECREAM152
59651-891-46BETAMETHASONE DIPROPIONATE1 in 1 CARTONCREAM12
59651-891-46BETAMETHASONE DIPROPIONATE45 g in 1 TUBECREAM452

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 DIPROPIONATEAurobindo Pharma Limiteda4f8db3a-0aed-451c-98ba-c4ce376567922026-05-04Adverse reactionsExact identifier
application applno (ANDA): 219348
application number: ANDA219348
ndc (product): 59651-891

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238920betamethasone 0.05 % Topical CreamPSNa4f8db3a-0aed-451c-98ba-c4ce376567922
238920betamethasone 0.5 MG/ML Topical CreamSCDa4f8db3a-0aed-451c-98ba-c4ce376567922
238920betamethasone 0.05 % Topical CreamSYa4f8db3a-0aed-451c-98ba-c4ce376567922
238920betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical CreamSYa4f8db3a-0aed-451c-98ba-c4ce376567922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-891-14596510891141 TUBE in 1 CARTON (59651-891-14) / 15 g in 1 TUBE1 tube2026-01-26NoNoCurrent
59651-891-46596510891461 TUBE in 1 CARTON (59651-891-46) / 45 g in 1 TUBE1 tube2026-01-26NoNoCurrent