Clobetasol Propionate

Product NDC
70710-1456
Requested package NDC
70710-1456-3
11-digit product format
707101456
Labeler code
70710
Product ID
70710-1456_81c51ba6-f3d8-4a34-9a8b-1834de862812
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA211074
Marketing category
ANDA
Marketing start
2019-01-09
Marketing end
0000-00-00
Substance
CLOBETASOL PROPIONATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70710-145670710-1456-3DDiscontinued by firm2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70710-145670710-1456-3DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70710-145670710-1456-3DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
A211074-001CLOBETASOL PROPIONATECLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211074-001AB1

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 06:07:402026-07A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-153f01610625f2…
2019-09-15 20:21 UTC2019-09A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211074-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-10-15e64feba35796…

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 06:07:402026-07A211074-001AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211074-001AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211074-001AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211074-001AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211074-001AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211074-001AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211074-001AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211074-001AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211074-001AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211074-001AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211074-001AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211074-001AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211074-001AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211074-001AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211074-001AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211074-001AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211074-001AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211074-001AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211074-001AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211074-001AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211074-001AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211074-001AB1187673890dc5c…
2021-03-12 10:30 UTC2021-03A211074-001AB115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211074-001AB118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211074-001AB11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211074-001AB113f01610625f2…
2019-09-15 20:21 UTC2019-09A211074-001AB11b00525d2431f…
2019-07-19 19:46 UTC2019-07A211074-001AB11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211074-001AB116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211074-001AB111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211074-001AB11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211074-001AB11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211074-001AB119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211074-001AB11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211074-001AB113f0d92c62455…
2023-05-13 08:27 UTC2023-05A211074-001AB11053a50430f4f…
2023-01-26 05:58 UTC2023-01A211074-001AB113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211074-001AB113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211074-001AB11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211074-001AB11e64feba35796…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1456-1GM - Gram70710-14569029c1d9-85b0-4cb0-a9d3-065514d20d2b12019-03-12
70710-1456-2GM - Gram70710-1456837a321b-4fc2-4103-b40e-4301d140756212019-03-12
70710-1456-3GM - Gram70710-1456ca85c61e-a01a-488e-a01c-47976f5bb7a712019-03-12
70710-1456-4GM - Gram70710-14564dd13530-fb1e-4a85-94a7-73d687e7574f12019-03-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1456-3707101456031 TUBE in 1 CARTON (70710-1456-3) > 60 g in 1 TUBE1 tube2019-01-090000-00-00NoNoCurrent