Tretinoin

Product NDC
51672-1394
11-digit product format
516721394
Labeler code
51672
Product ID
51672-1394_38ef297e-e4cb-0593-e063-6294a90a324d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA211644
Marketing category
ANDA
Marketing start
2019-01-25
Substance
TRETINOIN
Active strength
.5 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
TRETINOIN.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5688UTC01R
Rxcui106303

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
51672-1394-0Tretinoin1 in 1 CARTONCREAM13
51672-1394-0Tretinoin20 g in 1 TUBECREAM203
51672-1394-9Tretinoin1 in 1 CARTONCREAM13
51672-1394-9Tretinoin45 g in 1 TUBECREAM453

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1394-0GM - Gram51672-139418728361-63d0-401a-a001-0be22318ae9d12019-02-13
51672-1394-9GM - Gram51672-13941d6055c0-3882-4ade-bd78-fca33263342812019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1394TRETINOIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2Current NDC, Legacy NDC, 4 package rows20190129_2b0c8ee4-83a5-48f1-809a-9716131f7290.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106303tretinoin 0.05 % Topical CreamPSN2b0c8ee4-83a5-48f1-809a-9716131f72903
106303tretinoin 0.5 MG/ML Topical CreamSCD2b0c8ee4-83a5-48f1-809a-9716131f72903
106303tretinoin 0.05 % Topical CreamSY2b0c8ee4-83a5-48f1-809a-9716131f72903
106303tretinoin 0.05 % Topical CreamPSNdd7d2d2a-e764-7dfe-e053-2995a90a790a1
106303tretinoin 0.5 MG/ML Topical CreamSCDdd7d2d2a-e764-7dfe-e053-2995a90a790a1
106303tretinoin 0.05 % Topical CreamSYdd7d2d2a-e764-7dfe-e053-2995a90a790a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1394-0516721394001 TUBE in 1 CARTON (51672-1394-0) / 20 g in 1 TUBE1 tube2019-01-250000-00-00NoNoCurrent
51672-1394-9516721394091 TUBE in 1 CARTON (51672-1394-9) / 45 g in 1 TUBE1 tube2019-01-250000-00-00NoNoCurrent