FDA.reportPublic FDA data

Clindamycin Phosphate

Product NDC
72162-1395
Requested package NDC
72162-1395-6
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
2026-08-01 22:54:322026-06A214604-001CLINDAMYCIN PHOSPHATEEQ 1% BASELOTION / TOPICALAB2021-03-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A214604-001AB1a50c72e98297…

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 (package): 72162-1395-6
ndc (product): 72162-1395
ndc11 (package): 72162139506
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