Betamethasone Dipropionate

Product NDC
68071-4814
11-digit product format
680714814
Labeler code
68071
Product ID
68071-4814_1add9095-5135-157a-e063-6394a90ab926
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA076592
Marketing category
ANDA
Marketing start
2006-09-28
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

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-4814-58af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-4814-5834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-4814-51332a3947898…d4bfe170f9cd…

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
A076592-001BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076592-001AB

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 06:07:402026-07A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-093f01610625f2…
2019-09-15 20:21 UTC2019-09A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076592-001BETAMETHASONE DIPROPIONATEEQ 0.05% BASECREAM, AUGMENTED / TOPICALAB2003-12-09e64feba35796…

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 06:07:402026-07A076592-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076592-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076592-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076592-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076592-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076592-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076592-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076592-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076592-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076592-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076592-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076592-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076592-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076592-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076592-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076592-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076592-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076592-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076592-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076592-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076592-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076592-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076592-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076592-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076592-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076592-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076592-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076592-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076592-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076592-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076592-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076592-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076592-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076592-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076592-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076592-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076592-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076592-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076592-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076592-001AB1e64feba35796…

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
848176Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
84b37e6a-779e-5d43-e053-2a91aa0a16b7Available 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
68071-4814-5Betamethasone Dipropionate15 g in 1 TUBECREAM153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4814BETAMETHASONE DIPROPIONATE CREAM [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240616_84b37e6a-779e-5d43-e053-2a91aa0a16b7.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEPreferred Pharmaceuticals, Inc.5683885d-461c-4e7e-bbe8-dc231d7061922026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076592
application number: ANDA076592
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEBryant Ranch Prepackf2c557ea-275b-4ab4-90f4-4003e022214d2025-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076592
application number: ANDA076592
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEBryant Ranch Prepack0481ac0d-9220-472b-b3f2-af6e0bb6962d2024-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076592
application number: ANDA076592
Betamethasone DipropionateBETAMETHASONE DIPROPIONATENuCare Pharmaceuticals,Inc.84b37e6a-779e-5d43-e053-2a91aa0a16b72024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076592
application number: ANDA076592
ndc (product): 68071-4814
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEBryant Ranch Prepack79256f36-adff-4628-abc5-cb25bdfdc19d2024-01-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076592
application number: ANDA076592
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEPadagis Israel Pharmaceuticals Ltd7bd2646c-f34a-4824-8f66-c41e77db19d22023-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076592
application number: ANDA076592
Betamethasone DipropionateBETAMETHASONE DIPROPIONATEProficient Rx LPf1be7c91-5408-4d31-8673-b691089aadce2022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076592
application number: ANDA076592

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamPSN84b37e6a-779e-5d43-e053-2a91aa0a16b73
848176Augmented betamethasone 0.5 MG/ML Topical CreamSCD84b37e6a-779e-5d43-e053-2a91aa0a16b73
848176augmented betamethasone 0.05 % Topical CreamSY84b37e6a-779e-5d43-e053-2a91aa0a16b73
848176betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical CreamSY84b37e6a-779e-5d43-e053-2a91aa0a16b73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4814-56807148140515 g in 1 TUBE (68071-4814-5) 15 g2019-03-220000-00-00NoNoCurrent