FDA.reportPublic FDA data

ZIANA

Product NDC
99207-300
11-digit product format
992070300
Labeler code
99207
Product ID
99207-300_d765377b-8dc9-4a8e-b063-9903eb4f2176
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clindamycin phosphate and tretinoin
Dosage form
GEL
Route
TOPICAL
Labeler
Bausch Health US, LLC
Application
NDA050802
Marketing category
NDA
Marketing start
2006-12-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZIANA
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEH6D7113I8, 5688UTC01R
Rxcui882548, 882550

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
99207-300-02ZIANA12 in 1 CARTONGEL1210
99207-300-02ZIANA2 g in 1 TUBEGEL210
99207-300-30ZIANA30 g in 1 TUBEGEL3010
99207-300-30ZIANA1 in 1 CARTONGEL110
99207-300-60ZIANA60 g in 1 TUBEGEL6010
99207-300-60ZIANA1 in 1 CARTONGEL110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
99207-300-30GM - Gram99207-300ac9050e3-729a-43a9-962b-330b5f9e191812012-07-24
99207-300-60GM - Gram99207-3004ec6dcc6-317d-4ee0-b91d-d5077211ff1b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
clindamycin phosphateACTIVE INGREDIENTEH6D7113I8ZIANA (CLINDAMYCIN PHOSPHATE AND TRETINOIN) GEL [MEDICIS PHARMACEUTICAL CORP]5
tretinoinACTIVE INGREDIENT5688UTC01RZIANA (CLINDAMYCIN PHOSPHATE AND TRETINOIN) GEL [MEDICIS PHARMACEUTICAL CORP]5
clindamycinACTIVE MOIETY3U02EL437CZIANA (CLINDAMYCIN PHOSPHATE AND TRETINOIN) GEL [MEDICIS PHARMACEUTICAL CORP]5
tretinoinACTIVE MOIETY5688UTC01RZIANA (CLINDAMYCIN PHOSPHATE AND TRETINOIN) GEL [MEDICIS PHARMACEUTICAL CORP]5
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KZIANA (CLINDAMYCIN PHOSPHATE AND TRETINOIN) GEL [MEDICIS PHARMACEUTICAL CORP]5
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENTF68VH75CJCZIANA (CLINDAMYCIN PHOSPHATE AND TRETINOIN) GEL [MEDICIS PHARMACEUTICAL CORP]5
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPZIANA (CLINDAMYCIN PHOSPHATE AND TRETINOIN) GEL [MEDICIS PHARMACEUTICAL CORP]5
edetate disodiumINACTIVE INGREDIENT7FLD91C86KZIANA (CLINDAMYCIN PHOSPHATE AND TRETINOIN) GEL [MEDICIS PHARMACEUTICAL CORP]5
glycerinINACTIVE INGREDIENTPDC6A3C0OXZIANA (CLINDAMYCIN PHOSPHATE AND TRETINOIN) GEL [MEDICIS PHARMACEUTICAL CORP]5
methylparabenINACTIVE INGREDIENTA2I8C7HI9TZIANA (CLINDAMYCIN PHOSPHATE AND TRETINOIN) GEL [MEDICIS PHARMACEUTICAL CORP]5
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HZIANA (CLINDAMYCIN PHOSPHATE AND TRETINOIN) GEL [MEDICIS PHARMACEUTICAL CORP]5
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHZIANA (CLINDAMYCIN PHOSPHATE AND TRETINOIN) GEL [MEDICIS PHARMACEUTICAL CORP]5
tromethamineINACTIVE INGREDIENT023C2WHX2VZIANA (CLINDAMYCIN PHOSPHATE AND TRETINOIN) GEL [MEDICIS PHARMACEUTICAL CORP]5
waterINACTIVE INGREDIENT059QF0KO0RZIANA (CLINDAMYCIN PHOSPHATE AND TRETINOIN) GEL [MEDICIS PHARMACEUTICAL CORP]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
99207-300ZIANA (CLINDAMYCIN PHOSPHATE AND TRETINOIN) GEL [BAUSCH HEALTH US, LLC]8Current NDC, Legacy NDC, 6 package rows20191211_78c329f9-f0c9-486d-9e54-0123699fb9e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
882548clindamycin phosphate 1.2 % / tretinoin 0.025 % Topical GelPSN78c329f9-f0c9-486d-9e54-0123699fb9e110
882550ZIANA 1.2 % / 0.025 % Topical GelPSN78c329f9-f0c9-486d-9e54-0123699fb9e110
882550clindamycin phosphate 0.012 MG/MG / tretinoin 0.00025 MG/MG Topical Gel [Ziana]SBD78c329f9-f0c9-486d-9e54-0123699fb9e110
882548clindamycin phosphate 0.012 MG/MG / tretinoin 0.00025 MG/MG Topical GelSCD78c329f9-f0c9-486d-9e54-0123699fb9e110
882548clindamycin phosphate 1.2 % (clindamycin 1 % ) / tretinoin 0.025 % Topical GelSY78c329f9-f0c9-486d-9e54-0123699fb9e110
882550Ziana (clindamycin phosphate 1.2 % / tretinoin 0.025 % ) Topical GelSY78c329f9-f0c9-486d-9e54-0123699fb9e110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
99207-300-029920703000212 in 1 CARTONHistorical
99207-300-30992070300301 TUBE in 1 CARTON (99207-300-30) / 30 g in 1 TUBE1 tube2006-12-010000-00-00NoNoCurrent
99207-300-60992070300601 TUBE in 1 CARTON (99207-300-60) / 60 g in 1 TUBE1 tube2006-12-010000-00-00NoNoCurrent