Tretinoin

Product NDC
16714-249
11-digit product format
167140249
Labeler code
16714
Product ID
16714-249_39809045-c9fe-0fc5-e063-6394a90a60b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tretinoin
Dosage form
CREAM
Route
TOPICAL
Labeler
NORTHSTAR RX LLC
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
16714-249-01Tretinoin1 in 1 CARTONCREAM12
16714-249-01Tretinoin20 g in 1 TUBECREAM202
16714-249-02Tretinoin1 in 1 CARTONCREAM12
16714-249-02Tretinoin45 g in 1 TUBECREAM452

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-249-01GM - Gram16714-24971cf56e3-d5f3-48b8-92cb-1fc4c7d519bb12022-05-04
16714-249-02GM - Gram16714-2494899df5b-effd-4d46-a013-74da7b1c755b12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-249TRETINOIN CREAM [NORTHSTAR RX LLC]1Current NDC, Legacy NDC, 4 package rows20220305_2e508351-eca3-427e-8d16-e840a84db0f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106303tretinoin 0.05 % Topical CreamPSN44be2556-1ea9-49e9-86dd-991fbcc6348d6
106303tretinoin 0.5 MG/ML Topical CreamSCD44be2556-1ea9-49e9-86dd-991fbcc6348d6
106303tretinoin 0.05 % Topical CreamSY44be2556-1ea9-49e9-86dd-991fbcc6348d6
106303tretinoin 0.05 % Topical CreamPSN2e508351-eca3-427e-8d16-e840a84db0f52
106303tretinoin 0.5 MG/ML Topical CreamSCD2e508351-eca3-427e-8d16-e840a84db0f52
106303tretinoin 0.05 % Topical CreamSY2e508351-eca3-427e-8d16-e840a84db0f52
106303tretinoin 0.05 % Topical CreamPSN373dd14d-061a-4408-e063-6394a90abf951
106303tretinoin 0.5 MG/ML Topical CreamSCD373dd14d-061a-4408-e063-6394a90abf951
106303tretinoin 0.05 % Topical CreamSY373dd14d-061a-4408-e063-6394a90abf951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-249-01167140249011 TUBE in 1 CARTON (16714-249-01) / 20 g in 1 TUBE1 tube2022-02-250000-00-00NoNoCurrent
16714-249-02167140249021 TUBE in 1 CARTON (16714-249-02) / 45 g in 1 TUBE1 tube2022-02-250000-00-00NoNoCurrent