clindamycin phosphate

Product NDC
50090-0768
11-digit product format
500900768
Labeler code
50090
Product ID
50090-0768_6f15a879-eb5d-42c6-a009-de5b4feab887
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clindamycin phosphate
Dosage form
GEL
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA064160
Marketing category
ANDA
Marketing start
2000-01-28
Marketing end
0000-00-00
Substance
CLINDAMYCIN PHOSPHATE
Active strength
10 mg/g
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-0768IInactivated by FDA2026-08-17
excluded packagepackage50090-076850090-0768-0IInactivated by FDA2026-08-17

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-0768-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-0768-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-0768-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-0768-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-0768-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-0768-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-0768-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-0768-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-0768-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-0768-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-0768-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-0768-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-0768-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-0768-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-0768-01332a3947898…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
A064160-001CLINDAMYCIN PHOSPHATECLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A064160-001AB1

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 06:07:402026-07A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB2000-01-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB2000-01-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB2000-01-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB2000-01-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB2000-01-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB2000-01-283f01610625f2…
2019-09-15 20:21 UTC2019-09A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB2000-01-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB2000-01-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064160-001CLINDAMYCIN PHOSPHATEEQ 1% BASEGEL / TOPICALAB12000-01-28e64feba35796…

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 06:07:402026-07A064160-001AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A064160-001AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064160-001AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A064160-001AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064160-001AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064160-001AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064160-001AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064160-001AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064160-001AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064160-001AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064160-001AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064160-001AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064160-001AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064160-001AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064160-001AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064160-001AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064160-001AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064160-001AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064160-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064160-001AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064160-001AB11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064160-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A064160-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064160-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064160-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064160-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A064160-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A064160-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064160-001AB116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064160-001AB111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064160-001AB11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064160-001AB11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064160-001AB119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064160-001AB11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064160-001AB113f0d92c62455…
2023-05-13 08:27 UTC2023-05A064160-001AB11053a50430f4f…
2023-01-26 05:58 UTC2023-01A064160-001AB113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064160-001AB113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064160-001AB11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064160-001AB11e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d8f81258-db12-0761-46cc-8ff6e62e9302Product name420240422
b7b2fa42-1c77-d724-81f0-87da60a77e79Product name320240320
b27c7c65-51f2-a62f-e0e6-a26b3a0f8eb0Product name320230425
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
ffb4bacf-f636-0f7d-0b0d-7a4b151243e3Product name920220928
b72227d6-0388-43bd-995b-b762d2754cd5Product name120220706
a92d22e0-3af4-f301-bc88-27ff030b0070Product name220220316
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
5ce6ce33-4f2b-3ce0-757d-e520013280cfProduct name520180719
b92a26f1-6926-4817-be73-e26ab4c2146fProduct name120170602
028d6c95-5012-6976-2075-dee0ae6fefe2Product name120140508
468b2c08-8adb-8d0f-8257-c6515a061424Product name120140508
8959fb29-d86f-c521-666a-b4cb22233594Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0768-0clindamycin phosphate30 g in 1 TUBEGEL3015
50090-0768-0clindamycin phosphate1 in 1 CARTONGEL115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0768-0GM - Gram50090-0768b9ce7ac8-580a-4ad3-bd00-b1b4532b300b12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0768CLINDAMYCIN PHOSPHATE GEL [A-S MEDICATION SOLUTIONS]15Legacy NDC, 2 package rows20210616_e0a0221d-f1fc-470c-8646-8da33c815b8a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
clindamycin phosphateCLINDAMYCIN PHOSPHATEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC62a2019f-7410-4251-95ed-181925ade6e42026-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064160
application number: ANDA064160

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2676585clindamycin phosphate 1 % Twice-Daily Topical GelPSNe0a0221d-f1fc-470c-8646-8da33c815b8a15
2676585Twice-Daily clindamycin 0.01 MG/MG Topical GelSCDe0a0221d-f1fc-470c-8646-8da33c815b8a15
2676585clindamycin (as clindamycin phosphate) 1 % Twice-Daily Topical GelSYe0a0221d-f1fc-470c-8646-8da33c815b8a15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0768-0500900768001 TUBE in 1 CARTON (50090-0768-0) > 30 g in 1 TUBE1 tube2014-11-280000-00-00NoNoCurrent