FDA.reportPublic FDA data

Clindamycin Phosphate and Tretinoin

Product NDC
0472-1790
11-digit product format
004721790
Labeler code
0472
Product ID
0472-1790_8d92b9da-5fea-4457-a757-a589d443fd7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Phosphate and Tretinoin
Dosage form
GEL
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
ANDA202564
Marketing category
ANDA
Marketing start
2016-07-05
Substance
CLINDAMYCIN PHOSPHATE; TRETINOIN
Active strength
12; .25 mg/g; mg/g
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]
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 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
A202564-001CLINDAMYCIN PHOSPHATE AND TRETINOINCLINDAMYCIN PHOSPHATE; TRETINOIN1.2%;0.025%GEL / TOPICALAB12015-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202564-001AB1

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 22:54:322026-06A202564-001CLINDAMYCIN PHOSPHATE AND TRETINOIN1.2%;0.025%GEL / TOPICALAB12015-06-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202564-001AB11a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin Phosphate and TretinoinCLINDAMYCIN PHOSPHATE AND TRETINOINActavis Pharma, Inc.79e1c8f6-59cd-4efa-9efa-0762d4b1a10c2023-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202564
application number: ANDA202564
ndc (product): 0472-1790

Additional Listing Data#

Finished product
Yes
Brand name base
Clindamycin Phosphate and Tretinoin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN PHOSPHATE12 mg/g
TRETINOIN.25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EH6D7113I8Internal UNII lookup
5688UTC01RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
882548Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
79e1c8f6-59cd-4efa-9efa-0762d4b1a10cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60Product name620251124
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ecProduct name220250521
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
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
503b047e-e62d-4745-9011-522b13bc701bProduct name120181206
5ce6ce33-4f2b-3ce0-757d-e520013280cfProduct name520180719
b92a26f1-6926-4817-be73-e26ab4c2146fProduct name120170602
7d41caa2-0b5d-9b03-ab8d-84271de26ef4Product name220170314
50ca9ff5-82dd-9971-4f2c-5845a76a8572Product name220150818
028d6c95-5012-6976-2075-dee0ae6fefe2Product name120140508
0a8118e4-08c6-b395-9ddc-d3e425e0493aProduct name120140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579Product name120140508
468b2c08-8adb-8d0f-8257-c6515a061424Product name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
8959fb29-d86f-c521-666a-b4cb22233594Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0472-1790-30Clindamycin Phosphate and Tretinoin1 in 1 CARTONGEL113
0472-1790-30Clindamycin Phosphate and Tretinoin30 g in 1 TUBEGEL3013
0472-1790-60Clindamycin Phosphate and Tretinoin1 in 1 CARTONGEL113
0472-1790-60Clindamycin Phosphate and Tretinoin60 g in 1 TUBEGEL6013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-1790CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL [ACTAVIS PHARMA, INC.]13Current NDC, Legacy NDC, 4 package rows20240314_79e1c8f6-59cd-4efa-9efa-0762d4b1a10c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
882548clindamycin phosphate 1.2 % / tretinoin 0.025 % Topical GelPSN79e1c8f6-59cd-4efa-9efa-0762d4b1a10c13
882548clindamycin phosphate 0.012 MG/MG / tretinoin 0.00025 MG/MG Topical GelSCD79e1c8f6-59cd-4efa-9efa-0762d4b1a10c13
882548clindamycin phosphate 1.2 % (clindamycin 1 % ) / tretinoin 0.025 % Topical GelSY79e1c8f6-59cd-4efa-9efa-0762d4b1a10c13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-1790-30004721790301 TUBE in 1 CARTON (0472-1790-30) / 30 g in 1 TUBE1 tube2016-07-050000-00-00NoNoCurrent
0472-1790-60004721790601 TUBE in 1 CARTON (0472-1790-60) / 60 g in 1 TUBE1 tube2016-07-050000-00-00NoNoCurrent