Clindacin

Product NDC
43538-179
11-digit product format
435380179
Labeler code
43538
Product ID
43538-179_391b4472-8468-4d6f-bab0-406d83655cd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clindamycin phosphate
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Medimetriks Pharmaceuticals, Inc.
Application
ANDA090785
Marketing category
ANDA
Marketing start
2010-03-21
Substance
CLINDAMYCIN PHOSPHATE
Active strength
10 mg/g
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 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
A090785-001CLINDAMYCIN PHOSPHATECLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090785-001AT

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2010-03-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2010-03-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2010-03-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2010-03-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2010-03-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2010-03-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2010-03-3187673890dc5c…
2021-03-12 10:30 UTC2021-03A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2010-03-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2010-03-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2010-03-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2010-03-313f01610625f2…
2019-09-15 20:21 UTC2019-09A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2010-03-31b00525d2431f…
2019-07-19 19:46 UTC2019-07A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2010-03-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALATRS2010-03-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2010-03-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2010-03-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2010-03-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2010-03-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2010-03-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090785-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2010-03-31e64feba35796…

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 06:07:402026-07A090785-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090785-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090785-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090785-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090785-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090785-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090785-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090785-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090785-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090785-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090785-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090785-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090785-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090785-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090785-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090785-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090785-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090785-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090785-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090785-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090785-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090785-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A090785-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090785-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090785-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090785-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A090785-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090785-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090785-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090785-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090785-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090785-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090785-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090785-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090785-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090785-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090785-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090785-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090785-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090785-001AT1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN PHOSPHATE10 mg/g

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
477451Internal RxNorm lookup
2621717Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d01ffda3-1913-400d-a899-58b8face8936Available 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
43538-179-10Clindacin100 g in 1 CANAEROSOL, FOAM1001
43538-179-10Clindacin1 in 1 CARTONAEROSOL, FOAM11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43538-179-10GM - Gram43538-179f7920293-5208-43d0-af92-75592d426dec12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43538-179CLINDACIN (CLINDAMYCIN PHOSPHATE) AEROSOL, FOAM [MEDIMETRIKS PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 2 package rows20221130_d01ffda3-1913-400d-a899-58b8face8936.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEBryant Ranch Prepacka95020e2-9318-4a6b-8931-95771946638d2023-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090785
application number: ANDA090785
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEBryant Ranch Prepacke8086cf9-aa52-4aa5-815b-c76e8f145e0b2023-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090785
application number: ANDA090785
ClindacinCLINDAMYCIN PHOSPHATEMedimetriks Pharmaceuticals, Inc.d01ffda3-1913-400d-a899-58b8face89362022-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090785
application number: ANDA090785
ndc (product): 43538-179
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEPadagis Israel Pharmaceuticals Ltd2e6f96d0-d928-4775-a7db-3e998fce675b2022-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090785
application number: ANDA090785

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2621717Clindacin 1 % Topical FoamPSNd01ffda3-1913-400d-a899-58b8face89361
477451clindamycin phosphate 1 % Topical FoamPSNd01ffda3-1913-400d-a899-58b8face89361
2621717clindamycin 10 MG/ML Topical Foam [Clindacin]SBDd01ffda3-1913-400d-a899-58b8face89361
477451clindamycin 10 MG/ML Topical FoamSCDd01ffda3-1913-400d-a899-58b8face89361
2621717Clindacin (as clindamycin phosphate) 1 % Topical FoamSYd01ffda3-1913-400d-a899-58b8face89361
2621717Clindacin 10 MG/ML Topical FoamSYd01ffda3-1913-400d-a899-58b8face89361
477451clindamycin (as clindamycin phosphate) 1 % Topical FoamSYd01ffda3-1913-400d-a899-58b8face89361
477451clindamycin 1 % Topical FoamSYd01ffda3-1913-400d-a899-58b8face89361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43538-179-10435380179101 CAN in 1 CARTON (43538-179-10) / 100 g in 1 CAN1 can2022-11-140000-00-00NoNoCurrent