FDA.reportPublic FDA data

Clindamycin Phosphate

Product NDC
80005-131
11-digit product format
800050131
Labeler code
80005
Product ID
80005-131_afc7cc5c-76c8-4807-82c2-765f51bdacd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Phosphate Topical
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Carnegie Pharmaceuticals, LLC
Application
ANDA219612
Marketing category
ANDA
Marketing start
2025-06-16
Substance
CLINDAMYCIN PHOSPHATE
Active strength
10 mg/mL
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A219612-001CLINDAMYCIN PHOSPHATECLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALAT2025-06-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219612-001AT

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A219612-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALAT2025-06-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219612-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2025-06-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A219612-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2025-06-136a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219612-001CLINDAMYCIN PHOSPHATEEQ 1% BASESWAB / TOPICALAT2025-06-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219612-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219612-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219612-001AT16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219612-001AT1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Clindamycin Phosphate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN PHOSPHATE10 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309333Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c8fe61f1-f3c5-4452-9980-a727461b9844Available 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80005-131-09Clindamycin Phosphate1 mL in 1 APPLICATORSOLUTION13
80005-131-09Clindamycin Phosphate60 in 1 JARSOLUTION603
80005-131-38Clindamycin Phosphate69 in 1 JARSOLUTION693
80005-131-38Clindamycin Phosphate1 mL in 1 APPLICATORSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80005-131-09EA - Each80005-131b9844ca4-3f37-4c3e-b941-7d7b99778d1712025-07-08

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 PHOSPHATE TOPICALCarnegie Pharmaceuticals, LLCc8fe61f1-f3c5-4452-9980-a727461b98442025-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219612
application number: ANDA219612
ndc (product): 80005-131

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309333clindamycin phosphate 1 % Topical SolutionPSNc8fe61f1-f3c5-4452-9980-a727461b98443
309333clindamycin 10 MG/ML Topical SolutionSCDc8fe61f1-f3c5-4452-9980-a727461b98443
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSYc8fe61f1-f3c5-4452-9980-a727461b98443
309333clindamycin 1 % Topical SolutionSYc8fe61f1-f3c5-4452-9980-a727461b98443

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80005-131-098000501310960 APPLICATOR in 1 JAR (80005-131-09) / 1 mL in 1 APPLICATOR60 applicator2025-06-16NoNoCurrent
80005-131-388000501313869 APPLICATOR in 1 JAR (80005-131-38) / 1 mL in 1 APPLICATOR69 applicator2025-12-15NoNoCurrent