Clindamycin phosphate

Product NDC
70771-1414
11-digit product format
707711414
Labeler code
70771
Product ID
70771-1414_fed995d0-8469-4af3-af36-5c786e50799a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin phosphate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Zydus Lifesciences Limited
Application
ANDA208767
Marketing category
ANDA
Marketing start
2019-01-03
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
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
A208767-001CLINDAMYCIN PHOSPHATECLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208767-001AT

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 06:07:402026-07A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-163f01610625f2…
2019-09-15 20:21 UTC2019-09A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208767-001CLINDAMYCIN PHOSPHATEEQ 1% BASESOLUTION / TOPICALAT2018-07-16e64feba35796…

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 06:07:402026-07A208767-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208767-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208767-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208767-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208767-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208767-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208767-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208767-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208767-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208767-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208767-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208767-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208767-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208767-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208767-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208767-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208767-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208767-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208767-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208767-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208767-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208767-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A208767-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208767-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208767-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208767-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A208767-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208767-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208767-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208767-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208767-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208767-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208767-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208767-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208767-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208767-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208767-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208767-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208767-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208767-001AT1e64feba35796…

Additional Listing Data#

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

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
f1f7fb55-1676-4b9e-9f2f-9eaaf33a7633Available 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
70771-1414-2Clindamycin phosphate1 in 1 CARTONSOLUTION15
70771-1414-2Clindamycin phosphate30 mL in 1 BOTTLESOLUTION305
70771-1414-3Clindamycin phosphate1 in 1 CARTONSOLUTION15
70771-1414-3Clindamycin phosphate60 mL in 1 BOTTLESOLUTION605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1414CLINDAMYCIN PHOSPHATE SOLUTION [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 4 package rows20240817_f1f7fb55-1676-4b9e-9f2f-9eaaf33a7633.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEPreferred Pharmaceuticals Ince06d419f-4b60-405b-9459-e01bbb8d151d2026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208767
application number: ANDA208767
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEViona Pharmaceuticals Inc585e8b72-b350-451f-a232-199b1a01e8ce2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208767
application number: ANDA208767
Clindamycin phosphateCLINDAMYCIN PHOSPHATEZydus Lifesciences Limitedf1f7fb55-1676-4b9e-9f2f-9eaaf33a76332024-08-14Exact identifier
application applno (ANDA): 208767
application number: ANDA208767
ndc (product): 70771-1414

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309333clindamycin phosphate 1 % Topical SolutionPSNf1f7fb55-1676-4b9e-9f2f-9eaaf33a76335
309333clindamycin 10 MG/ML Topical SolutionSCDf1f7fb55-1676-4b9e-9f2f-9eaaf33a76335
309333clindamycin (as clindamycin phosphate) 1 % Topical SolutionSYf1f7fb55-1676-4b9e-9f2f-9eaaf33a76335
309333clindamycin 1 % Topical SolutionSYf1f7fb55-1676-4b9e-9f2f-9eaaf33a76335

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1414-2707711414021 BOTTLE in 1 CARTON (70771-1414-2) / 30 mL in 1 BOTTLE1 bottle2019-01-030000-00-00NoNoCurrent
70771-1414-3707711414031 BOTTLE in 1 CARTON (70771-1414-3) / 60 mL in 1 BOTTLE1 bottle2019-01-030000-00-00NoNoCurrent