FDA.reportPublic FDA data

foster and thrive nicotine

Product NDC
70677-1167
11-digit product format
706771167
Labeler code
70677
Product ID
70677-1167_ed441987-007c-4bf4-91c4-bec140cb7189
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA076789
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
70677-1167-1foster and thrive nicotine50 in 1 CARTONGUM, CHEWING502
70677-1167-1foster and thrive nicotine1 in 1 BLISTER PACKGUM, CHEWING12
70677-1167-2foster and thrive nicotine1 in 1 BLISTER PACKGUM, CHEWING12
70677-1167-2foster and thrive nicotine110 in 1 CARTONGUM, CHEWING1102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1167-1EA - Each70677-116713254207-083f-4950-a6d5-77962327b68312024-08-12
70677-1167-2EA - Each70677-116782b2e956-6a5b-49f8-a64f-df94e363d39212024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1167FOSTER AND THRIVE NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 4 package rows20230910_d146d768-b975-462c-bc94-c2132e1bdac7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311975nicotine polacrilex 4 MG Chewing GumPSNd146d768-b975-462c-bc94-c2132e1bdac72
311975nicotine 4 MG Chewing GumSCDd146d768-b975-462c-bc94-c2132e1bdac72
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSYd146d768-b975-462c-bc94-c2132e1bdac72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1167-17067711670150 BLISTER PACK in 1 CARTON (70677-1167-1) / 1 GUM, CHEWING in 1 BLISTER PACK50 blister pack2023-08-28NoNoHistorical
70677-1167-270677116702110 BLISTER PACK in 1 CARTON (70677-1167-2) / 1 GUM, CHEWING in 1 BLISTER PACK110 blister pack2023-08-28NoNoHistorical