FDA.reportPublic FDA data

Dapsone

Product NDC
16714-975
11-digit product format
167140975
Labeler code
16714
Product ID
16714-975_3980db5f-3ff2-2443-e063-6394a90ab484
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dapsone
Dosage form
GEL
Route
TOPICAL
Labeler
NORTHSTAR RX LLC
Application
ANDA210191
Marketing category
ANDA
Marketing start
2023-10-06
Substance
DAPSONE
Active strength
75 mg/g
Pharmacologic classes
Sulfone [EPC], Sulfones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DAPSONE75 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8W5C518302
Rxcui1741905

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ae3f83f-9ccb-db71-5718-0b1e959868dfProduct name520260113
5ae2790a-f798-4a69-8811-64a4723c389aProduct name520250325
b8929bfc-0002-d39a-046d-72ddf714efbeProduct name620190618

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-975-01Dapsone1 in 1 CARTONGEL12
16714-975-01Dapsone60 g in 1 BOTTLE, PUMPGEL602
16714-975-02Dapsone90 g in 1 BOTTLE, PUMPGEL902
16714-975-02Dapsone1 in 1 CARTONGEL12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-975-01GM - Gram16714-9754f6f6882-f438-4950-8d90-0e6e0e601b4612024-01-04
16714-975-02GM - Gram16714-975bc403fc3-33c2-47aa-93a8-c951a4d0cae712024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-975DAPSONE GEL [NORTHSTAR RX LLC ]1Current NDC, 4 package rows20231030_51ebcb4d-4368-4748-a6f3-1ec2100fed63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741905dapsone 7.5 % Topical GelPSN51ebcb4d-4368-4748-a6f3-1ec2100fed632
1741905dapsone 0.075 MG/MG Topical GelSCD51ebcb4d-4368-4748-a6f3-1ec2100fed632
1741905dapsone 7.5 % Topical GelSY51ebcb4d-4368-4748-a6f3-1ec2100fed632

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
16714-975-01167140975011 BOTTLE, PUMP in 1 CARTON (16714-975-01) / 60 g in 1 BOTTLE, PUMP2023-10-06NoNoCurrent
16714-975-02167140975021 BOTTLE, PUMP in 1 CARTON (16714-975-02) / 90 g in 1 BOTTLE, PUMP2023-10-06NoNoCurrent