Clobetasol Propionate

Product NDC
70700-109
11-digit product format
707000109
Labeler code
70700
Product ID
70700-109_3c32f122-0b2c-5c00-e063-6294a90a0a95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Xiromed, LLC
Application
ANDA210034
Marketing category
ANDA
Marketing start
2018-06-19
Substance
CLOBETASOL PROPIONATE
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 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
A210034-001CLOBETASOL PROPIONATECLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210034-001AB1

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 06:07:402026-07A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-153f01610625f2…
2019-09-15 20:21 UTC2019-09A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-15e64feba35796…

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 06:07:402026-07A210034-001AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210034-001AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210034-001AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210034-001AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210034-001AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210034-001AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210034-001AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210034-001AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210034-001AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210034-001AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210034-001AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210034-001AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210034-001AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210034-001AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210034-001AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210034-001AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210034-001AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210034-001AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210034-001AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210034-001AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210034-001AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210034-001AB1187673890dc5c…
2021-03-12 10:30 UTC2021-03A210034-001AB115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210034-001AB118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210034-001AB11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210034-001AB113f01610625f2…
2019-09-15 20:21 UTC2019-09A210034-001AB11b00525d2431f…
2019-07-19 19:46 UTC2019-07A210034-001AB11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210034-001AB116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210034-001AB111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210034-001AB11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210034-001AB11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210034-001AB119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210034-001AB11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210034-001AB113f0d92c62455…
2023-05-13 08:27 UTC2023-05A210034-001AB11053a50430f4f…
2023-01-26 05:58 UTC2023-01A210034-001AB113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210034-001AB113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210034-001AB11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210034-001AB11e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Clobetasol Propionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOBETASOL PROPIONATE.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
779619577MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861495Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2556987f-4b0f-8a83-5bf4-095d67a450b4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
20abe2c3-3e80-d2b2-39eb-3156e4af4799Product name320250124
45ad92f8-d116-4c0c-851c-2e740b7d8e6fProduct name120250122
42be0ad5-6fd7-4f1b-8108-6d9dd7d571dfProduct name720250107
3813b789-94b9-edd6-f010-6b926dd462e5Product name520230113
30eee8a1-850e-41ed-b5ab-761301aeab49Product name620221206
18e5b6f7-c414-b1f1-b684-17fdd02c215eProduct name420210927
1c87bbde-dd91-a122-db33-67ae814cb645Product name720210510
519b5875-7d7d-4aa6-9d3d-470fa1376595Product name420200227
98669154-3e9c-47da-8a2c-656ab71848beProduct name220180607
8d4f8539-436f-453b-8b76-5322d403fc8eProduct name120180131
837ac3c6-ee71-c5a6-6eba-c4065f37e9f5Product name220171010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70700-109-15Clobetasol Propionate15 g in 1 TUBECREAM159
70700-109-15Clobetasol Propionate1 in 1 CARTONCREAM19
70700-109-16Clobetasol Propionate1 in 1 CARTONCREAM19
70700-109-16Clobetasol Propionate30 g in 1 TUBECREAM309
70700-109-17Clobetasol Propionate60 g in 1 TUBECREAM609
70700-109-17Clobetasol Propionate1 in 1 CARTONCREAM19
70700-109-18Clobetasol Propionate1 in 1 CARTONCREAM19
70700-109-18Clobetasol Propionate45 g in 1 TUBECREAM459

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-109-15GM - Gram70700-10971f5d1fe-d2f8-4b31-a1d0-92827d9be98112018-11-06
70700-109-16GM - Gram70700-109587dd34a-fe17-44b8-a27c-83500ccef67512018-11-06
70700-109-17GM - Gram70700-109c8da7f30-34d8-4ff4-986a-39d948e9701412018-11-06
70700-109-18GM - Gram70700-10915dbe110-7b7c-46fe-963d-c4b341bf987512018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-109CLOBETASOL PROPIONATE CREAM [XIROMED, LLC]8Current NDC, Legacy NDC, 8 package rows20230707_2556987f-4b0f-8a83-5bf4-095d67a450b4.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
Clobetasol PropionateCLOBETASOL PROPIONATEBryant Ranch Prepack4990e4c7-78b3-4bc8-85d0-6d58f08121ff2025-11-04Adverse reactionsExact identifier
application applno (ANDA): 210034
application number: ANDA210034
Clobetasol PropionateCLOBETASOL PROPIONATEBryant Ranch Prepack9856b731-0676-405d-817c-de385cbd08a32025-09-30Adverse reactionsExact identifier
application applno (ANDA): 210034
application number: ANDA210034
Clobetasol PropionateCLOBETASOL PROPIONATEBryant Ranch Prepack643682ee-39c8-4a0d-b131-f30077e6e20a2025-09-03Adverse reactionsExact identifier
application applno (ANDA): 210034
application number: ANDA210034
Clobetasol PropionateCLOBETASOL PROPIONATEBryant Ranch Prepack21a63bc2-a42a-412c-8dd5-17e279f99f272025-09-03Adverse reactionsExact identifier
application applno (ANDA): 210034
application number: ANDA210034
Clobetasol PropionateCLOBETASOL PROPIONATEBryant Ranch Prepack6d14d269-bae6-493a-81ed-83f6a3aa0f4f2025-09-03Adverse reactionsExact identifier
application applno (ANDA): 210034
application number: ANDA210034
Clobetasol PropionateCLOBETASOL PROPIONATEXiromed, LLC2556987f-4b0f-8a83-5bf4-095d67a450b42025-08-12Adverse reactionsExact identifier
application applno (ANDA): 210034
application number: ANDA210034
ndc (product): 70700-109
Clobetasol PropionateCLOBETASOL PROPIONATEA-S Medication Solutions52bf5318-2487-4c7b-aa8d-e98f22cc61042023-07-27Adverse reactionsExact identifier
application applno (ANDA): 210034
application number: ANDA210034

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861495clobetasol propionate 0.05 % Topical CreamPSN9856b731-0676-405d-817c-de385cbd08a3104
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD9856b731-0676-405d-817c-de385cbd08a3104
861495clobetasol propionate 0.05 % Topical CreamSY9856b731-0676-405d-817c-de385cbd08a3104
861495clobetasol propionate 0.05 % Topical CreamPSN21a63bc2-a42a-412c-8dd5-17e279f99f27103
861495clobetasol propionate 0.05 % Topical CreamPSN6d14d269-bae6-493a-81ed-83f6a3aa0f4f103
861495clobetasol propionate 0.05 % Topical CreamPSN643682ee-39c8-4a0d-b131-f30077e6e20a103
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD21a63bc2-a42a-412c-8dd5-17e279f99f27103
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD6d14d269-bae6-493a-81ed-83f6a3aa0f4f103
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD643682ee-39c8-4a0d-b131-f30077e6e20a103
861495clobetasol propionate 0.05 % Topical CreamSY21a63bc2-a42a-412c-8dd5-17e279f99f27103
861495clobetasol propionate 0.05 % Topical CreamSY6d14d269-bae6-493a-81ed-83f6a3aa0f4f103
861495clobetasol propionate 0.05 % Topical CreamSY643682ee-39c8-4a0d-b131-f30077e6e20a103
861495clobetasol propionate 0.05 % Topical CreamPSN4990e4c7-78b3-4bc8-85d0-6d58f08121ff101
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD4990e4c7-78b3-4bc8-85d0-6d58f08121ff101
861495clobetasol propionate 0.05 % Topical CreamSY4990e4c7-78b3-4bc8-85d0-6d58f08121ff101
861495clobetasol propionate 0.05 % Topical CreamPSN2556987f-4b0f-8a83-5bf4-095d67a450b49
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD2556987f-4b0f-8a83-5bf4-095d67a450b49
861495clobetasol propionate 0.05 % Topical CreamSY2556987f-4b0f-8a83-5bf4-095d67a450b49
861495clobetasol propionate 0.05 % Topical CreamPSN52bf5318-2487-4c7b-aa8d-e98f22cc61048
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD52bf5318-2487-4c7b-aa8d-e98f22cc61048
861495clobetasol propionate 0.05 % Topical CreamSY52bf5318-2487-4c7b-aa8d-e98f22cc61048

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70700-109-15707000109151 TUBE in 1 CARTON (70700-109-15) / 15 g in 1 TUBE1 tube2018-06-190000-00-00NoNoCurrent
70700-109-16707000109161 TUBE in 1 CARTON (70700-109-16) / 30 g in 1 TUBE1 tube2018-06-190000-00-00NoNoCurrent
70700-109-17707000109171 TUBE in 1 CARTON (70700-109-17) / 60 g in 1 TUBE1 tube2018-06-190000-00-00NoNoCurrent
70700-109-18707000109181 TUBE in 1 CARTON (70700-109-18) / 45 g in 1 TUBE1 tube2018-06-190000-00-00NoNoCurrent