Clobetasol Propionate

Product NDC
70700-106
11-digit product format
707000106
Labeler code
70700
Product ID
70700-106_c89c3b09-de28-9c1d-1f88-db05969f1868
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Xiromed, LLC
Application
ANDA209701
Marketing category
ANDA
Marketing start
2018-05-01
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 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
A209701-001CLOBETASOL PROPIONATECLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209701-001AB

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 UTC2026-02A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-173f01610625f2…
2019-09-15 20:21 UTC2019-09A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209701-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2018-04-17cb3db0bc1861…

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 UTC2026-02A209701-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209701-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209701-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209701-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209701-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209701-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209701-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209701-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209701-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209701-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209701-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209701-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209701-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209701-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209701-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209701-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209701-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209701-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209701-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209701-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209701-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A209701-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209701-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209701-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209701-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A209701-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209701-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209701-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209701-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209701-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209701-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209701-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209701-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209701-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209701-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209701-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209701-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209701-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209701-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209701-001AB1cb3db0bc1861…

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
861448Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
56e6d233-d9ee-f022-3be7-d100799a561eAvailable 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
70700-106-15Clobetasol Propionate15 g in 1 TUBEOINTMENT1517
70700-106-16Clobetasol Propionate30 g in 1 TUBEOINTMENT3017
70700-106-17Clobetasol Propionate60 g in 1 TUBEOINTMENT6017
70700-106-18Clobetasol Propionate45 g in 1 TUBEOINTMENT4517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-106-15GM - Gram70700-10696391f03-78f1-44ca-ab65-3e185403ae6812018-10-11
70700-106-16GM - Gram70700-10671b551d5-2dbe-4292-b149-f59d11dd06a212018-10-11
70700-106-17GM - Gram70700-1062939524f-2db0-4d19-9e64-c4498a2ebb8612018-10-11
70700-106-18GM - Gram70700-106b60d5430-6a45-48f7-ab60-ac9bf1c8b37d12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-106CLOBETASOL PROPIONATE OINTMENT [XIROMED, LLC]17Current NDC, Legacy NDC, 4 package rows20230707_56e6d233-d9ee-f022-3be7-d100799a561e.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
Clobetasol PropionateCLOBETASOL PROPIONATEAvKAREa862de41-1500-9136-e053-2a95a90a60802023-07-03Adverse reactionsExact identifier
application applno (ANDA): 209701
application number: ANDA209701
Clobetasol PropionateCLOBETASOL PROPIONATEA-S Medication Solutionsf8e06ea9-bd18-48db-9f53-8e75734c8f012023-03-27Adverse reactionsExact identifier
application applno (ANDA): 209701
application number: ANDA209701
Clobetasol PropionateCLOBETASOL PROPIONATEXiromed, LLC56e6d233-d9ee-f022-3be7-d100799a561e2020-11-06Adverse reactionsExact identifier
application applno (ANDA): 209701
application number: ANDA209701
ndc (product): 70700-106

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861448clobetasol propionate 0.05 % Topical OintmentPSN56e6d233-d9ee-f022-3be7-d100799a561e17
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD56e6d233-d9ee-f022-3be7-d100799a561e17
861448clobetasol propionate 0.05 % Topical OintmentSY56e6d233-d9ee-f022-3be7-d100799a561e17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70700-106-157070001061515 g in 1 TUBE (70700-106-15) 15 g2018-05-010000-00-00NoNoCurrent
70700-106-167070001061630 g in 1 TUBE (70700-106-16) 30 g2018-05-010000-00-00NoNoCurrent
70700-106-177070001061760 g in 1 TUBE (70700-106-17) 60 g2018-05-010000-00-00NoNoCurrent
70700-106-187070001061845 g in 1 TUBE (70700-106-18) 45 g2018-05-010000-00-00NoNoCurrent