FDA.reportPublic FDA data

foster and thrive nicotine

Product NDC
70677-1164
11-digit product format
706771164
Labeler code
70677
Product ID
70677-1164_7079d131-81b0-43f5-81f2-c25c2efa3ae8
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA078547
Marketing category
ANDA
Marketing start
2024-06-19
Substance
NICOTINE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
foster and thrive nicotine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R
Rxcui314119

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
70677-1164-1foster and thrive nicotine1 in 1 BLISTER PACKGUM, CHEWING13
70677-1164-1foster and thrive nicotine100 in 1 CARTONGUM, CHEWING1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1164-1EA - Each70677-1164b8f1a8c6-8139-455b-987f-1d52b7b38dae12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1164FOSTER AND THRIVE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 2 package rows20240621_c5290759-84c0-4999-8222-d03a0b61bcd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNc5290759-84c0-4999-8222-d03a0b61bcd53
314119nicotine 2 MG Chewing GumSCDc5290759-84c0-4999-8222-d03a0b61bcd53
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYc5290759-84c0-4999-8222-d03a0b61bcd53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1164-170677116401100 BLISTER PACK in 1 CARTON (70677-1164-1) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2024-06-19NoNoHistorical