FDA.reportPublic FDA data

Foster and Thrive Nicotine

Product NDC
70677-1166
11-digit product format
706771166
Labeler code
70677
Product ID
70677-1166_58b95145-65a4-40d8-ba5e-cbe9afd81717
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA076775
Marketing category
ANDA
Marketing start
2024-03-23
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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1166-1Foster and Thrive Nicotine1 in 1 BLISTER PACKGUM, CHEWING13
70677-1166-1Foster and Thrive Nicotine50 in 1 CARTONGUM, CHEWING503
70677-1166-2Foster and Thrive Nicotine1 in 1 BLISTER PACKGUM, CHEWING13
70677-1166-2Foster and Thrive Nicotine110 in 1 CARTONGUM, CHEWING1103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1166-1EA - Each70677-11667c982fea-ec00-4e83-a1ea-09dc624cba8212024-07-12
70677-1166-2EA - Each70677-1166f0f1a948-d8b6-44e3-b565-6e29dc70e47c12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1166FOSTER AND THRIVE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 4 package rows20240328_b3dc0d9a-f85d-4d8a-b212-bddb692f85b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNb3dc0d9a-f85d-4d8a-b212-bddb692f85b83
314119nicotine 2 MG Chewing GumSCDb3dc0d9a-f85d-4d8a-b212-bddb692f85b83
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYb3dc0d9a-f85d-4d8a-b212-bddb692f85b83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1166-17067711660150 BLISTER PACK in 1 CARTON (70677-1166-1) / 1 GUM, CHEWING in 1 BLISTER PACK50 blister pack2024-03-23NoNoHistorical
70677-1166-270677116602110 BLISTER PACK in 1 CARTON (70677-1166-2) / 1 GUM, CHEWING in 1 BLISTER PACK110 blister pack2024-03-23NoNoHistorical