FDA.reportPublic FDA data

BLIP

Product NDC
82966-269
11-digit product format
829660269
Labeler code
82966
Product ID
82966-269_b8cdecaa-1582-4d1c-8858-48d883a42c53
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine Polacrilex
Dosage form
GUM, CHEWING
Route
ORAL
Labeler
Blip Products, Inc.
Application
ANDA206394
Marketing category
ANDA
Marketing start
2023-03-14
Substance
NICOTINE
Active strength
2 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
BLIP
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M3C89ZY6R

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
82966-269-60BLIP20 in 1 CARTONGUM, CHEWING202
82966-269-60BLIP1 in 1 BLISTER PACKGUM, CHEWING12
82966-269-78BLIP100 in 1 CARTONGUM, CHEWING1002
82966-269-78BLIP1 in 1 BLISTER PACKGUM, CHEWING12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82966-269BLIP (NICOTINE POLACRILEX) GUM, CHEWING [BLIP PRODUCTS, INC.]2Current NDC, 4 package rows20250305_ad5fc90e-d3b4-4701-bfd8-1cda9087d09a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314119nicotine polacrilex 2 MG Chewing GumPSNad5fc90e-d3b4-4701-bfd8-1cda9087d09a2
314119nicotine 2 MG Chewing GumSCDad5fc90e-d3b4-4701-bfd8-1cda9087d09a2
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSYad5fc90e-d3b4-4701-bfd8-1cda9087d09a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82966-269-608296602696020 BLISTER PACK in 1 CARTON (82966-269-60) / 1 GUM, CHEWING in 1 BLISTER PACK20 blister pack2023-03-14NoNoCurrent
82966-269-7882966026978100 BLISTER PACK in 1 CARTON (82966-269-78) / 1 GUM, CHEWING in 1 BLISTER PACK100 blister pack2023-03-14NoNoCurrent