FDA.reportPublic FDA data

Betamethasone dipropionate

Product NDC
16714-996
11-digit product format
167140996
Labeler code
16714
Product ID
16714-996_66c8f094-ba44-41e8-8917-3800f05152fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Betamethasone dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Northstar Rx LLC.
Application
ANDA208885
Marketing category
ANDA
Marketing start
2019-10-10
Substance
BETAMETHASONE DIPROPIONATE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAMETHASONE DIPROPIONATE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii826Y60901U
Rxcui238920

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-996-01Betamethasone dipropionate15 g in 1 TUBECREAM154
16714-996-01Betamethasone dipropionate1 in 1 CARTONCREAM14
16714-996-02Betamethasone dipropionate45 g in 1 TUBECREAM454
16714-996-02Betamethasone dipropionate1 in 1 CARTONCREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-996-01GM - Gram16714-99685b729d8-54a5-4324-9977-cc43c956064f12020-03-10
16714-996-02GM - Gram16714-996322c77c8-9f50-4e08-9fd4-703f5495887912020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-996BETAMETHASONE DIPROPIONATE CREAM [NORTHSTAR RX LLC.]4Current NDC, Legacy NDC, 4 package rows20241207_395d40c0-22d9-48d1-8d8e-eeaddf33c53e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238920betamethasone 0.05 % Topical CreamPSN395d40c0-22d9-48d1-8d8e-eeaddf33c53e4
238920betamethasone 0.5 MG/ML Topical CreamSCD395d40c0-22d9-48d1-8d8e-eeaddf33c53e4
238920betamethasone 0.05 % Topical CreamSY395d40c0-22d9-48d1-8d8e-eeaddf33c53e4
238920betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical CreamSY395d40c0-22d9-48d1-8d8e-eeaddf33c53e4
238920betamethasone 0.05 % Topical CreamPSN07a35811-7298-4f25-b280-e2f9aeab98301
238920betamethasone 0.5 MG/ML Topical CreamSCD07a35811-7298-4f25-b280-e2f9aeab98301
238920betamethasone 0.05 % Topical CreamSY07a35811-7298-4f25-b280-e2f9aeab98301
238920betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical CreamSY07a35811-7298-4f25-b280-e2f9aeab98301

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-996-01167140996011 TUBE in 1 CARTON (16714-996-01) / 15 g in 1 TUBE1 tube2019-10-100000-00-00NoNoCurrent
16714-996-02167140996021 TUBE in 1 CARTON (16714-996-02) / 45 g in 1 TUBE1 tube2019-10-100000-00-00NoNoCurrent