FDA.reportPublic FDA data

Tretinoin

Product NDC
51672-1395
11-digit product format
516721395
Labeler code
51672
Product ID
51672-1395_38ef2970-1212-d2fa-e063-6394a90a7570
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA211645
Marketing category
ANDA
Marketing start
2019-01-22
Substance
TRETINOIN
Active strength
1 mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRETINOIN1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5688UTC01R
Rxcui198300

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60Product name620251124
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ecProduct name220250521
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
503b047e-e62d-4745-9011-522b13bc701bProduct name120181206
7d41caa2-0b5d-9b03-ab8d-84271de26ef4Product name220170314
50ca9ff5-82dd-9971-4f2c-5845a76a8572Product name220150818
0a8118e4-08c6-b395-9ddc-d3e425e0493aProduct name120140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579Product name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1395-0Tretinoin1 in 1 CARTONCREAM14
51672-1395-0Tretinoin20 g in 1 TUBECREAM204
51672-1395-9Tretinoin45 g in 1 TUBECREAM454
51672-1395-9Tretinoin1 in 1 CARTONCREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1395-0GM - Gram51672-13957aee2208-9d93-496b-8275-e88d1fe1588412019-02-13
51672-1395-9GM - Gram51672-13950304f81f-3bc8-4221-b7c0-3f534d27604e12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1395TRETINOIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 4 package rows20190126_9e964be5-8d67-46a8-888e-0351f9113f68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198300tretinoin 0.1 % Topical CreamPSNda206984-4ded-4d5c-8a23-323920466a5f10
198300tretinoin 1 MG/ML Topical CreamSCDda206984-4ded-4d5c-8a23-323920466a5f10
198300tretinoin 0.1 % Topical CreamSYda206984-4ded-4d5c-8a23-323920466a5f10
198300tretinoin 0.1 % Topical CreamPSN9e964be5-8d67-46a8-888e-0351f9113f684
198300tretinoin 1 MG/ML Topical CreamSCD9e964be5-8d67-46a8-888e-0351f9113f684
198300tretinoin 0.1 % Topical CreamSY9e964be5-8d67-46a8-888e-0351f9113f684
198300tretinoin 0.1 % Topical CreamPSNbcfdf523-dcf7-44f3-8ef6-a517a0f265b42
198300tretinoin 1 MG/ML Topical CreamSCDbcfdf523-dcf7-44f3-8ef6-a517a0f265b42
198300tretinoin 0.1 % Topical CreamSYbcfdf523-dcf7-44f3-8ef6-a517a0f265b42
198300tretinoin 0.1 % Topical CreamPSN31d2cd00-e534-6755-e063-6394a90ab8bb1
198300tretinoin 1 MG/ML Topical CreamSCD31d2cd00-e534-6755-e063-6394a90ab8bb1
198300tretinoin 0.1 % Topical CreamSY31d2cd00-e534-6755-e063-6394a90ab8bb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1395-0516721395001 TUBE in 1 CARTON (51672-1395-0) / 20 g in 1 TUBE1 tube2019-01-220000-00-00NoNoCurrent
51672-1395-9516721395091 TUBE in 1 CARTON (51672-1395-9) / 45 g in 1 TUBE1 tube2019-01-220000-00-00NoNoCurrent