Clindamycin Phosphate

Product NDC
52565-018
11-digit product format
525650018
Labeler code
52565
Product ID
52565-018_a65fad55-7b26-4def-915d-8aeb41cb7165
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Phosphate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA206945
Marketing category
ANDA
Marketing start
2016-12-30
Marketing end
0000-00-00
Substance
CLINDAMYCIN PHOSPHATE
Active strength
10 mg/mL
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52565-018IInactivated by FDA2026-08-03
excluded packagepackage52565-01852565-018-29IInactivated by FDA2026-08-03
excluded packagepackage52565-01852565-018-59IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 36 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-03-28 20:22 UTC · source 2025-03-28excluded productproduct52565-018IInactivated by FDAexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52565-01852565-018-29IInactivated by FDAexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52565-01852565-018-59IInactivated by FDAexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproduct52565-018IInactivated by FDAexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52565-01852565-018-29IInactivated by FDAexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52565-01852565-018-59IInactivated by FDAexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproduct52565-018IInactivated by FDAexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52565-01852565-018-29IInactivated by FDAexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52565-01852565-018-59IInactivated by FDAexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct52565-018IInactivated by FDAexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52565-01852565-018-29IInactivated by FDAexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52565-01852565-018-59IInactivated by FDAexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct52565-018IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52565-01852565-018-29IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52565-01852565-018-59IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct52565-018IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52565-01852565-018-29IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage52565-01852565-018-59IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct52565-018IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52565-01852565-018-29IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage52565-01852565-018-59IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct52565-018IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52565-01852565-018-29IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage52565-01852565-018-59IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct52565-018IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52565-01852565-018-29IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage52565-01852565-018-59IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct52565-018IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52565-01852565-018-29IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage52565-01852565-018-59IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct52565-018IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52565-01852565-018-29IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage52565-01852565-018-59IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct52565-018IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52565-01852565-018-29IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage52565-01852565-018-59IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
A206945-001CLINDAMYCIN PHOSPHATECLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICAL2016-12-30

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 UTC2026-02A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICAL2016-12-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICAL2016-12-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICAL2016-12-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICAL2016-12-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICAL2016-12-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICAL2016-12-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICAL2016-12-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICAL2016-12-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICAL2016-12-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICAL2016-12-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICAL2016-12-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICAL2016-12-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICAL2016-12-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICAL2016-12-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2016-12-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2016-12-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2016-12-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2016-12-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2016-12-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2016-12-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2016-12-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2016-12-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2016-12-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2016-12-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2016-12-303f01610625f2…
2019-09-15 20:21 UTC2019-09A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2016-12-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2016-12-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICAL2016-12-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICAL2016-12-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICAL2016-12-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICAL2016-12-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICAL2016-12-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2016-12-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2016-12-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2016-12-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2016-12-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2016-12-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2016-12-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2016-12-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206945-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2016-12-30cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206945-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206945-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206945-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206945-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206945-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206945-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206945-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A206945-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206945-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206945-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206945-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A206945-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206945-001AT1ea99ee380514…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206945-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206945-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A206945-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A206945-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206945-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206945-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206945-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206945-001AT1cb3db0bc1861…

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
52565-018-29Clindamycin Phosphate1 in 1 CARTONSOLUTION15
52565-018-29Clindamycin Phosphate30 mL in 1 BOTTLE, WITH APPLICATORSOLUTION305
52565-018-59Clindamycin Phosphate60 mL in 1 BOTTLE, WITH APPLICATORSOLUTION605
52565-018-59Clindamycin Phosphate1 in 1 CARTONSOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-018-29ML - Milliliter52565-01881ca0537-d2be-4b3f-a80d-6ac0fba4a12d12017-04-05
52565-018-59ML - Milliliter52565-018ccc3ed54-e0cc-482b-87e3-155b6d7648f712017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-018CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) SOLUTION [TELIGENT PHARMA, INC.]5Legacy NDC, 4 package rows20190910_ef28ddda-00a4-471d-aae6-871f644742bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309333clindamycin phosphate 1 % Topical SolutionPSNef28ddda-00a4-471d-aae6-871f644742bd5
309333clindamycin 10 MG/ML Topical SolutionSCDef28ddda-00a4-471d-aae6-871f644742bd5
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSYef28ddda-00a4-471d-aae6-871f644742bd5
309333clindamycin 1 % Topical SolutionSYef28ddda-00a4-471d-aae6-871f644742bd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52565-018-29525650018291 BOTTLE, WITH APPLICATOR in 1 CARTON (52565-018-29) > 30 mL in 1 BOTTLE, WITH APPLICATOR2016-12-300000-00-00NoNoCurrent
52565-018-59525650018591 BOTTLE, WITH APPLICATOR in 1 CARTON (52565-018-59) > 60 mL in 1 BOTTLE, WITH APPLICATOR2016-12-300000-00-00NoNoCurrent