Clindamycin Phosphate

Product NDC
72162-1395
11-digit product format
721621395
Labeler code
72162
Product ID
72162-1395_e0269215-4ad0-4c19-90bb-dea6f969ef73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clindamycin phosphate
Dosage form
LOTION
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA214604
Marketing category
ANDA
Marketing start
2021-03-31
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
A214604-001CLINDAMYCIN PHOSPHATECLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214604-001AB

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 UTC2026-02A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-084b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-0887673890dc5c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-08cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214604-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214604-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214604-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214604-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214604-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214604-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214604-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214604-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214604-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214604-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214604-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214604-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214604-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214604-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214604-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214604-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214604-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214604-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214604-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A214604-001AB187673890dc5c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214604-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214604-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214604-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214604-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214604-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214604-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214604-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A214604-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A214604-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214604-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214604-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214604-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214604-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214604-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEBryant Ranch Prepack5c08f86e-abd7-4717-b902-74ea336ce28a2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214604
application number: ANDA214604
ndc (product): 72162-1395
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEBryant Ranch Prepack654477df-5cbb-491a-8aec-651598b768842025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214604
application number: ANDA214604
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEBryant Ranch Prepack00fe3546-a166-412f-a543-0ae7763c0ca02024-03-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214604
application number: ANDA214604
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEBryant Ranch Prepackac50088c-ba8c-4cca-a473-83011af80e852024-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214604
application number: ANDA214604
Clindamycin PhosphateCLINDAMYCIN PHOSPHATEPadagis Israel Pharmaceuticals Ltda10dda0c-28fa-4678-8cea-a6ce2fce4b522023-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214604
application number: ANDA214604

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
197519Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5c08f86e-abd7-4717-b902-74ea336ce28aAvailable 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
72162-1395-6Clindamycin Phosphate60 mL in 1 BOTTLELOTION60101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1395-6ML - Milliliter72162-1395a208c8e3-4ccb-4721-b7c4-653ea4c07e4e12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1395CLINDAMYCIN PHOSPHATE LOTION [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20240315_5c08f86e-abd7-4717-b902-74ea336ce28a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197519clindamycin phosphate 1 % Topical LotionPSN5c08f86e-abd7-4717-b902-74ea336ce28a101
197519clindamycin 10 MG/ML Topical LotionSCD5c08f86e-abd7-4717-b902-74ea336ce28a101
197519clindamycin (as clindamycin phosphate) 1 % Topical LotionSY5c08f86e-abd7-4717-b902-74ea336ce28a101
197519clindamycin 1 % Topical LotionSY5c08f86e-abd7-4717-b902-74ea336ce28a101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1395-67216213950660 mL in 1 BOTTLE (72162-1395-6) 60 ml2024-03-13NoNoCurrent