Clindamycin Phosphate

Product NDC
53002-8370
Requested package NDC
53002-8370-1
11-digit product format
530028370
Labeler code
53002
Product ID
53002-8370_d6ecce6b-2cc2-49db-901c-d043a6aa830f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Phosphate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA064050
Marketing category
ANDA
Marketing start
2013-09-17
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
2021-12-31
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 packagepackage53002-837053002-8370-1IInactivated by FDA2026-08-03

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 · 11 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
A064050-001CLINDAMYCIN PHOSPHATECLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A064050-001AT

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 UTC2026-02A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT1995-11-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT1995-11-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT1995-11-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT1995-11-303f01610625f2…
2019-09-15 20:21 UTC2019-09A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT1995-11-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT1995-11-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064050-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALATRS1995-11-30cb3db0bc1861…

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 UTC2026-02A064050-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064050-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A064050-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064050-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064050-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064050-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064050-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064050-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064050-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064050-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064050-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064050-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064050-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064050-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064050-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064050-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064050-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064050-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064050-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064050-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064050-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A064050-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064050-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064050-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064050-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A064050-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A064050-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064050-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064050-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064050-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064050-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064050-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064050-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064050-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A064050-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A064050-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064050-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064050-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064050-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064050-001AT1cb3db0bc1861…

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
53002-8370-1Clindamycin Phosphate30 mL in 1 BOTTLE, WITH APPLICATORSOLUTION305
53002-8370-1Clindamycin Phosphate1 in 1 CARTONSOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-8370CLINDAMYCIN PHOSPHATE SOLUTION [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20230609_eb1c0b65-391b-493e-864b-ac231da1e3f7.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
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEBryant Ranch Prepack25706fd8-d5e2-488b-9888-ee76d2686e192026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064050
application number: ANDA064050
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEBryant Ranch Prepack576fbdf8-b44d-49bf-a569-601861cc402d2026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064050
application number: ANDA064050
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEBryant Ranch Prepack27747e01-85eb-44de-a4a6-711a7799218a2026-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064050
application number: ANDA064050
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEPadagis Israel Pharmaceuticals Ltd461ab478-3cf6-4e9b-ba7d-0331b379cacf2026-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064050
application number: ANDA064050
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEBryant Ranch Prepackc22fb382-afbc-4b2d-bdce-e97e21bddb232026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064050
application number: ANDA064050
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEBryant Ranch Prepack34f7a271-c012-6463-e063-6394a90ad1ea2026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064050
application number: ANDA064050
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEA-S Medication Solutionsba3f54e5-1ff5-4ffd-8ed2-f15439f423e92025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064050
application number: ANDA064050

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309333clindamycin phosphate 1 % Topical SolutionPSNeb1c0b65-391b-493e-864b-ac231da1e3f75
309333clindamycin 10 MG/ML Topical SolutionSCDeb1c0b65-391b-493e-864b-ac231da1e3f75
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSYeb1c0b65-391b-493e-864b-ac231da1e3f75
309333clindamycin 1 % Topical SolutionSYeb1c0b65-391b-493e-864b-ac231da1e3f75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-8370-1530028370011 BOTTLE, WITH APPLICATOR in 1 CARTON (53002-8370-1) > 30 mL in 1 BOTTLE, WITH APPLICATOR2018-10-010000-00-00NoNoCurrent