Home NDC 70677-0032 Nicotine
Product NDC 70677-0032
11-digit product format 706770032
Labeler code 70677
Product ID 70677-0032_3b272bb9-e522-8dfa-e063-6294a90a18cc
Type HUMAN OTC DRUG
Nonproprietary name Nicotine
Dosage form PATCH
Route TRANSDERMAL
Labeler Strategic Sourcing Services LLC
Application ANDA074612
Marketing category ANDA
Marketing start 2017-12-04
Marketing end 2027-02-28
Substance NICOTINE
Active strength 21 mg/24h
Pharmacologic classes Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074612-001 NICOTINE NICOTINE 21MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL 1997-10-20 A074612-002 NICOTINE NICOTINE 7MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL 2003-07-28 A074612-003 NICOTINE NICOTINE 14MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL 1997-10-20
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A074612-001 NICOTINE 21MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL 1997-10-20 a50c72e98297…2026-08-01 22:54:32 2026-06 A074612-002 NICOTINE 7MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL 2003-07-28 a50c72e98297…2026-08-01 22:54:32 2026-06 A074612-003 NICOTINE 14MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL 1997-10-20 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 17 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Nicotine Active Ingredients# Ingredient, Strength table Ingredient Strength NICOTINE 21 mg/24h
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6M3C89ZY6R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198029 Internal RxNorm lookup 198030 Internal RxNorm lookup 198031 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70677-0032-1 Nicotine 14 in 1 CARTON PATCH 14 10 70677-0032-1 Nicotine 1 h in 1 POUCH PATCH 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70677-0032 NICOTINE PATCH [STRATEGIC SOURCING SERVICES LLC] 9 Current NDC, Legacy NDC, 2 package rows 20230713_a08022ff-e412-47f9-8132-318f55528c5c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70677-0032-1 70677003201 14 POUCH in 1 CARTON (70677-0032-1) / 1 h in 1 POUCH 14 pouch 2017-12-04 2027-02-28 No No Current