Clindamycin Phosphate

Product NDC
68462-605
11-digit product format
684620605
Labeler code
68462
Product ID
68462-605_65e63c9a-9be2-43c3-bbab-4b03df80e3a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Phosphate
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
GLENMARK PHARMACEUTICALS INC., USA
Application
ANDA210778
Marketing category
ANDA
Marketing start
2024-01-23
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
2027-12-31
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
A210778-001CLINDAMYCIN PHOSPHATECLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210778-001AT

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
2026-08-18 06:07:402026-07A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-204b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-20782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-20cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210778-001CLINDAMYCIN PHOSPHATE1%AEROSOL, FOAM / TOPICALAT2021-09-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A210778-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210778-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210778-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210778-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210778-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210778-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210778-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210778-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210778-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210778-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210778-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210778-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210778-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210778-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210778-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210778-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210778-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210778-001AT14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210778-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210778-001AT1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210778-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210778-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210778-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210778-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210778-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210778-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210778-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A210778-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A210778-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210778-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210778-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210778-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A210778-001AT1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210778-001AT1a50c72e98297…

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/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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d0ec3e88-40d9-4919-afc3-cf2e7e863376Available 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
68462-605-27Clindamycin Phosphate50 g in 1 CANAEROSOL, FOAM502
68462-605-27Clindamycin Phosphate1 in 1 CARTONAEROSOL, FOAM12
68462-605-94Clindamycin Phosphate1 in 1 CARTONAEROSOL, FOAM12
68462-605-94Clindamycin Phosphate100 g in 1 CANAEROSOL, FOAM1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-605-27GM - Gram68462-605ef3676c1-23d9-48ed-bf35-d523f77474af12025-03-04
68462-605-94GM - Gram68462-605859c3609-902f-4d59-b633-7705cac448bc12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-605CLINDAMYCIN PHOSPHATE AEROSOL, FOAM [GLENMARK PHARMACEUTICALS INC., USA]1Current NDC, 4 package rows20240208_d0ec3e88-40d9-4919-afc3-cf2e7e863376.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEGLENMARK PHARMACEUTICALS INC., USAd0ec3e88-40d9-4919-afc3-cf2e7e8633762026-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210778
application number: ANDA210778
ndc (product): 68462-605

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477451clindamycin phosphate 1 % Topical FoamPSNd0ec3e88-40d9-4919-afc3-cf2e7e8633762
477451clindamycin 10 MG/ML Topical FoamSCDd0ec3e88-40d9-4919-afc3-cf2e7e8633762
477451clindamycin (as clindamycin phosphate) 1 % Topical FoamSYd0ec3e88-40d9-4919-afc3-cf2e7e8633762
477451clindamycin 1 % Topical FoamSYd0ec3e88-40d9-4919-afc3-cf2e7e8633762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68462-605-27684620605271 CAN in 1 CARTON (68462-605-27) / 50 g in 1 CAN1 can2024-01-23NoNoCurrent
68462-605-94684620605941 CAN in 1 CARTON (68462-605-94) / 100 g in 1 CAN1 can2024-01-23NoNoCurrent