FDA.reportPublic FDA data

foster and thrive nicotine

Product NDC
70677-1193
11-digit product format
706771193
Labeler code
70677
Product ID
70677-1193_56441e3e-248c-4ab6-af17-06dad4bd5666
Type
HUMAN OTC DRUG
Nonproprietary name
nicotine polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA206393
Marketing category
ANDA
Marketing start
2023-08-28
Substance
NICOTINE
Active strength
4 mg/1
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 nicotine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui311975

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
70677-1193-1foster and thrive nicotine110 in 1 CARTONGUM, CHEWING1102
70677-1193-1foster and thrive nicotine1 in 1 BLISTER PACKGUM, CHEWING12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1193-1EA - Each70677-1193839deb0c-da6e-438d-a341-b026f334e87f12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1193FOSTER AND THRIVE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 2 package rows20230914_c6c9582c-004d-4925-b147-add5f28f3856.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNc6c9582c-004d-4925-b147-add5f28f38562
311975nicotine 4 MG Chewing GumSCDc6c9582c-004d-4925-b147-add5f28f38562
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYc6c9582c-004d-4925-b147-add5f28f38562

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1193-170677119301110 BLISTER PACK in 1 CARTON (70677-1193-1) / 1 GUM, CHEWING in 1 BLISTER PACK110 blister pack2023-08-28NoNoCurrent