FDA.reportPublic FDA data

foster and thrive STEP 2

Product NDC
70677-1181
11-digit product format
706771181
Labeler code
70677
Product ID
70677-1181_1a9da2c5-09e0-f87a-e063-6394a90abfe3
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Transdermal System
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA074612
Marketing category
ANDA
Marketing start
2024-06-25
Substance
NICOTINE
Active strength
14 mg/24h
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
foster and thrive STEP 2
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE14 mg/24h

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui198029, 198030, 198031

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1181-1foster and thrive STEP 224 h in 1 POUCHPATCH242
70677-1181-1foster and thrive STEP 214 in 1 CARTONPATCH142

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1181-1EA - Each70677-1181f9667081-ce1c-4757-bef1-1873655ac91112024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1181FOSTER AND THRIVE STEP 1 (NICOTINE TRANSDERMAL SYSTEM) PATCH FOSTER AND THRIVE STEP 2 (NICOTINE TRANSDERMAL SYSTEM) PATCH FOSTER AND THRIVE STEP 3 (NICOTINE TRANSDERMAL SYSTEM) PATCH [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 2 package rows20240625_d992645a-f185-48be-887a-e89ab5fcf039.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNd992645a-f185-48be-887a-e89ab5fcf0392
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNd992645a-f185-48be-887a-e89ab5fcf0392
198031nicotine 7 MG/Day 24HR Transdermal SystemPSNd992645a-f185-48be-887a-e89ab5fcf0392
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCDd992645a-f185-48be-887a-e89ab5fcf0392
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDd992645a-f185-48be-887a-e89ab5fcf0392
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDd992645a-f185-48be-887a-e89ab5fcf0392
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSYd992645a-f185-48be-887a-e89ab5fcf0392
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYd992645a-f185-48be-887a-e89ab5fcf0392
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYd992645a-f185-48be-887a-e89ab5fcf0392
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYd992645a-f185-48be-887a-e89ab5fcf0392
198029nicotine 14 MG/Day 24HR Transdermal SystemSYd992645a-f185-48be-887a-e89ab5fcf0392
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYd992645a-f185-48be-887a-e89ab5fcf0392
198030nicotine 21 MG/Day 24HR Transdermal SystemSYd992645a-f185-48be-887a-e89ab5fcf0392
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSYd992645a-f185-48be-887a-e89ab5fcf0392
198031nicotine 7 MG/Day 24HR Transdermal SystemSYd992645a-f185-48be-887a-e89ab5fcf0392

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1181-17067711810114 POUCH in 1 CARTON (70677-1181-1) / 24 h in 1 POUCH14 pouch2024-06-25NoNoCurrent