Clindamycin Phosphate

Product NDC
50090-5779
11-digit product format
500905779
Labeler code
50090
Product ID
50090-5779_583d05a5-b7e7-4b29-97b0-2d861f80fd55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Phosphate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA209846
Marketing category
ANDA
Marketing start
2020-03-01
Substance
CLINDAMYCIN PHOSPHATE
Active strength
11.9 mg/mL
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
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
A209846-001CLINDAMYCIN PHOSPHATECLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209846-001AT

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 UTC2026-02A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-083f01610625f2…
2019-09-15 20:21 UTC2019-09A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209846-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-02-08cb3db0bc1861…

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 UTC2026-02A209846-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209846-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209846-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209846-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209846-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209846-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209846-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209846-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209846-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209846-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209846-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209846-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209846-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209846-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209846-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209846-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209846-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209846-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209846-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209846-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209846-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A209846-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209846-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209846-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209846-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A209846-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209846-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209846-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209846-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209846-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209846-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209846-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209846-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209846-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209846-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209846-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209846-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209846-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209846-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209846-001AT1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Clindamycin Phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN PHOSPHATE11.9 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EH6D7113I8Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
44759c4f-5c87-4347-800f-83bb7487fff0Available on FDA.report

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5779-02023-02-07C16284748780-1f386c64a-2b25-0266-e053-dadaa90a7c1aClindamycin Phosphate
50090-5779-02023-01-30C16284748780-1f386c64a-2b25-0266-e053-dadaa90a7c1aClindamycin Phosphate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5779-0Clindamycin Phosphate60 mL in 1 BOTTLE, WITH APPLICATORSOLUTION605
50090-5779-0Clindamycin Phosphate1 in 1 CARTONSOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5779-0ML - Milliliter50090-5779850861bd-a1e3-40a7-b1ba-6d3d1b20044012024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5779CLINDAMYCIN PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20231204_44759c4f-5c87-4347-800f-83bb7487fff0.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEChartwell RX, LLC7740ed35-ff93-4c5e-8983-934ff7b86da72025-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209846
application number: ANDA209846
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEA-S Medication Solutions44759c4f-5c87-4347-800f-83bb7487fff02023-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209846
application number: ANDA209846
ndc (product): 50090-5779

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5779-0500905779001 BOTTLE, WITH APPLICATOR in 1 CARTON (50090-5779-0) / 60 mL in 1 BOTTLE, WITH APPLICATOR2021-10-070000-00-00NoNoCurrent