Nicotine

Product NDC
43598-448
11-digit product format
435980448
Labeler code
43598
Product ID
43598-448_15710e2c-e365-1726-06de-fb172f976a3b
Type
HUMAN OTC DRUG
Nonproprietary name
Nicotine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
NDA020076
Marketing category
NDA
Marketing start
2015-05-14
Substance
NICOTINE
Active strength
21 mg/24h
Pharmacologic classes
Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43598-448DDiscontinued by firm2026-08-17
excluded packagepackage43598-44843598-448-28DDiscontinued by firm2026-08-17
excluded packagepackage43598-44843598-448-70DDiscontinued by firm2026-08-17
excluded packagepackage43598-44843598-448-74DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43598-448-28d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43598-448-70d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43598-448-74d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43598-448-28f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43598-448-70f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43598-448-74f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43598-448-282ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43598-448-702ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43598-448-742ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43598-448-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43598-448-70a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43598-448-74a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43598-448-28cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43598-448-70cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43598-448-74cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43598-448-28cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43598-448-70cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43598-448-74cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43598-448-28302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43598-448-70302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43598-448-74302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43598-448-28ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43598-448-70ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43598-448-74ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43598-448-280efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43598-448-700efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43598-448-740efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43598-448-28ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43598-448-70ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43598-448-74ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43598-448-28367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43598-448-70367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43598-448-74367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43598-448-28557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43598-448-70557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43598-448-74557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020076-004HABITROLNICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12
N020076-005HABITROLNICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12
N020076-006HABITROLNICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12

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.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12caaa826d4ba7…
2026-08-18 06:07:402026-07N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12caaa826d4ba7…
2026-08-18 06:07:402026-07N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-121e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Nicotine
Brand name suffix
transdermal system step 1
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NICOTINE21 mg/24h

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6M3C89ZY6RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198029Internal RxNorm lookup
198030Internal RxNorm lookup
198031Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3a68eb70-0548-fa6f-8b1c-375e8799f24fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43598-448-282024-01-30C16284748780-11030e365-641d-111a-e063-dadaa90a10e2Drug Facts
43598-448-702024-01-30C16284748780-11030e365-641d-111a-e063-dadaa90a10e2Drug Facts
43598-448-742024-01-30C16284748780-11030e365-641d-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-448-28Nicotine transdermal system step 128 in 1 CARTONPATCH, EXTENDED RELEASE2811
43598-448-28Nicotine transdermal system step 124 h in 1 PATCHPATCH, EXTENDED RELEASE2411
43598-448-70Nicotine transdermal system step 124 h in 1 PATCHPATCH, EXTENDED RELEASE2411
43598-448-70Nicotine transdermal system step 17 in 1 CARTONPATCH, EXTENDED RELEASE711
43598-448-74Nicotine transdermal system step 124 h in 1 PATCHPATCH, EXTENDED RELEASE2411
43598-448-74Nicotine transdermal system step 114 in 1 CARTONPATCH, EXTENDED RELEASE1411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-448-28EA - Each43598-448c86cd4a5-6444-46cd-873f-f9832e13937212015-06-09
43598-448-70EA - Each43598-448e4d89091-c12a-4ad9-aa48-0846078f336612015-06-09
43598-448-74EA - Each43598-448d8e6f24d-9214-4b58-bb52-e65cc3d6b43e12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC.]3
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC.]3
Methacrylic AcidINACTIVE INGREDIENT1CS02G8656NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC.]3
NICOTINEACTIVE INGREDIENT6M3C89ZY6RHEALTHMART NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE HEALTHMART NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE HEALTHMART NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [MCKESSON]2
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [WALGREENS COMPANY]2
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [CVS PHARMACY]2
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [CARDINAL HEALTH (LEADER)]2
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [THE KROGER CO.]2
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [CARDINAL HEALTH (LEADER)]2
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [THE KROGER CO.]2
NICOTINEACTIVE MOIETY6M3C89ZY6RHEALTHMART NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE HEALTHMART NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE HEALTHMART NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [MCKESSON]2
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [CVS PHARMACY]2
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [WALGREENS COMPANY]2
Methacrylic AcidINACTIVE INGREDIENT1CS02G8656NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [CARDINAL HEALTH (LEADER)]2
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656HEALTHMART NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE HEALTHMART NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE HEALTHMART NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [MCKESSON]2
Methacrylic AcidINACTIVE INGREDIENT1CS02G8656NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [CVS PHARMACY]2
Methacrylic AcidINACTIVE INGREDIENT1CS02G8656NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [WALGREENS COMPANY]2
Methacrylic AcidINACTIVE INGREDIENT1CS02G8656NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [THE KROGER CO.]2
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [MCKESSON (SUN MARK)]1
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [MCKESSON (SUN MARK)]1
Methacrylic AcidINACTIVE INGREDIENT1CS02G8656NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [MCKESSON (SUN MARK)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-448NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE [DR. REDDY'S LABORATORIES INC.]11Current NDC, Legacy NDC, 6 package rows20240726_3a68eb70-0548-fa6f-8b1c-375e8799f24f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine Transdermal System Patch Step 3NICOTINE TRANSDERMAL SYSTEM PATCHBluePoint Laboratories4856e99a-badc-b957-e063-6294a90a86062026-07-10WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine Transdermal System step 3NICOTINEAmerisourceBergen Drug Corporatione51d2c09-a20f-eb9b-e3e4-013f3e488ab32026-07-01WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINERugby Laboratoriesae406389-0f83-d5c8-bd2f-56075e57453a2026-03-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine Transdermal System step 3NICOTINECARDINAL HEALTH 110, LLC. DBA LEADERdbbed17b-8ad3-05fb-fb63-03fbb75eae052026-03-18WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
NICOTINE TRANSDERMAL SYSTEMNICOTINEA-S Medication Solutionscfb56e3e-ac5d-4086-a5d3-23080844b3e12026-03-13WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINEGolden State Medical Supply, Inc.7c83d507-7e8d-496c-bb9d-63abfa25c7a72025-04-17WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINECVS Pharmacyd51d5224-f5bf-2510-1fa0-c4bb454f81602024-12-01WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINEStrategic Sourcing Services LLC6c0b5b5c-cc76-6e48-c364-4db0e081557d2024-11-09WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINERite Aid Corporationd2e32434-ec58-943e-dbeb-8e73315315952024-07-26WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
NICOTINE TRANSDERMALNICOTINERite Aid Corporationae6027da-5c96-ed47-e1ae-e900fc0f72ce2024-07-26WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINEThe Kroger Co.13cdd780-4196-685b-3cab-f9694a3276182024-07-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Habitrol Step 3NICOTINE TRANSDERMAL SYSTEM PATCHDr. Reddy's Laboratories Inc.051be7ae-6504-c2d8-7424-2e328e4fcfc22024-07-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 2NICOTINEChain Drug Marketing Association INCdf1348cb-0d15-7e4b-921c-d8764c858e662024-07-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal systemNICOTINEDr. Reddys Laboratories Inc.e2391b29-9bac-fc09-f2a5-a3370bc4e2c32024-07-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
nicotine transdermal systemNICOTINEDr. Reddy's Laboratories Inc.b9946e3c-80c9-3076-7c32-e2988ac070482024-07-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 1NICOTINEDOLGENCORP, LLC81e55db2-897e-e567-5743-63179783291a2024-07-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINEWalgreens Companyde471db4-b332-0490-198d-d354802728742024-07-25WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
Nicotine transdermal system step 3NICOTINEDr. Reddy's Laboratories Inc.3a68eb70-0548-fa6f-8b1c-375e8799f24f2024-07-24WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076
ndc (product): 43598-448
Nicotine transdermal system step 3NICOTINEA-S Medication Solutions798a66fa-25d8-4713-b25f-56875431e37d2023-03-02WarningsExact identifier
application applno (NDA): 020076
application number: NDA020076

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNcfb56e3e-ac5d-4086-a5d3-23080844b3e122
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDcfb56e3e-ac5d-4086-a5d3-23080844b3e122
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYcfb56e3e-ac5d-4086-a5d3-23080844b3e122
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYcfb56e3e-ac5d-4086-a5d3-23080844b3e122
198030nicotine 21 MG/Day 24HR Transdermal SystemSYcfb56e3e-ac5d-4086-a5d3-23080844b3e122
198029nicotine 14 MG/Day 24HR Transdermal SystemPSN721a31b6-20b3-4b1f-b019-82849af6ecdd19
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN721a31b6-20b3-4b1f-b019-82849af6ecdd19
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN44536fb0-dc5d-4c50-8d10-19dd9a0d997819
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCD721a31b6-20b3-4b1f-b019-82849af6ecdd19
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD721a31b6-20b3-4b1f-b019-82849af6ecdd19
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD44536fb0-dc5d-4c50-8d10-19dd9a0d997819
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSY721a31b6-20b3-4b1f-b019-82849af6ecdd19
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY721a31b6-20b3-4b1f-b019-82849af6ecdd19
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY44536fb0-dc5d-4c50-8d10-19dd9a0d997819
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSY721a31b6-20b3-4b1f-b019-82849af6ecdd19
198029nicotine 14 MG/Day 24HR Transdermal SystemSY721a31b6-20b3-4b1f-b019-82849af6ecdd19
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY721a31b6-20b3-4b1f-b019-82849af6ecdd19
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY44536fb0-dc5d-4c50-8d10-19dd9a0d997819
198030nicotine 21 MG/Day 24HR Transdermal SystemSY44536fb0-dc5d-4c50-8d10-19dd9a0d997819
198030nicotine 21 MG/Day 24HR Transdermal SystemSY721a31b6-20b3-4b1f-b019-82849af6ecdd19
198029nicotine 14 MG/Day 24HR Transdermal SystemPSN3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNd51d5224-f5bf-2510-1fa0-c4bb454f816011
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNd51d5224-f5bf-2510-1fa0-c4bb454f816011
198031nicotine 7 MG/Day 24HR Transdermal SystemPSNd51d5224-f5bf-2510-1fa0-c4bb454f816011
198031nicotine 7 MG/Day 24HR Transdermal SystemPSN3a68eb70-0548-fa6f-8b1c-375e8799f24f11
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCDd51d5224-f5bf-2510-1fa0-c4bb454f816011
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCD3a68eb70-0548-fa6f-8b1c-375e8799f24f11
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDd51d5224-f5bf-2510-1fa0-c4bb454f816011
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCD3a68eb70-0548-fa6f-8b1c-375e8799f24f11
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD3a68eb70-0548-fa6f-8b1c-375e8799f24f11
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDd51d5224-f5bf-2510-1fa0-c4bb454f816011
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198029nicotine 14 MG/Day 24HR Transdermal SystemSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198029nicotine 14 MG/Day 24HR Transdermal SystemSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198030nicotine 21 MG/Day 24HR Transdermal SystemSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
198030nicotine 21 MG/Day 24HR Transdermal SystemSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
198031nicotine 7 MG/Day 24HR Transdermal SystemSYd51d5224-f5bf-2510-1fa0-c4bb454f816011
198031nicotine 7 MG/Day 24HR Transdermal SystemSY3a68eb70-0548-fa6f-8b1c-375e8799f24f11
198029nicotine 14 MG/Day 24HR Transdermal SystemPSNde471db4-b332-0490-198d-d3548027287410
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNde471db4-b332-0490-198d-d3548027287410
198030nicotine 21 MG/Day 24HR Transdermal SystemPSNf7b564df-4a69-48cc-a0b0-8f8bedd64d8010
198031nicotine 7 MG/Day 24HR Transdermal SystemPSNde471db4-b332-0490-198d-d3548027287410
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCDde471db4-b332-0490-198d-d3548027287410
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCDde471db4-b332-0490-198d-d3548027287410
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDde471db4-b332-0490-198d-d3548027287410
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCDf7b564df-4a69-48cc-a0b0-8f8bedd64d8010
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSYde471db4-b332-0490-198d-d3548027287410
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSYde471db4-b332-0490-198d-d3548027287410
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYf7b564df-4a69-48cc-a0b0-8f8bedd64d8010
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSYde471db4-b332-0490-198d-d3548027287410
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSYde471db4-b332-0490-198d-d3548027287410
198029nicotine 14 MG/Day 24HR Transdermal SystemSYde471db4-b332-0490-198d-d3548027287410
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYde471db4-b332-0490-198d-d3548027287410
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSYf7b564df-4a69-48cc-a0b0-8f8bedd64d8010
198030nicotine 21 MG/Day 24HR Transdermal SystemSYde471db4-b332-0490-198d-d3548027287410
198030nicotine 21 MG/Day 24HR Transdermal SystemSYf7b564df-4a69-48cc-a0b0-8f8bedd64d8010
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSYde471db4-b332-0490-198d-d3548027287410
198031nicotine 7 MG/Day 24HR Transdermal SystemSYde471db4-b332-0490-198d-d3548027287410
198029nicotine 14 MG/Day 24HR Transdermal SystemPSN13cdd780-4196-685b-3cab-f9694a3276189
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN13cdd780-4196-685b-3cab-f9694a3276189
198031nicotine 7 MG/Day 24HR Transdermal SystemPSN13cdd780-4196-685b-3cab-f9694a3276189
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCD13cdd780-4196-685b-3cab-f9694a3276189
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCD13cdd780-4196-685b-3cab-f9694a3276189
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD13cdd780-4196-685b-3cab-f9694a3276189
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSY13cdd780-4196-685b-3cab-f9694a3276189
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSY13cdd780-4196-685b-3cab-f9694a3276189
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY13cdd780-4196-685b-3cab-f9694a3276189
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSY13cdd780-4196-685b-3cab-f9694a3276189

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-448-284359804482828 PATCH in 1 CARTON (43598-448-28) / 24 h in 1 PATCH28 patch2019-03-310000-00-00NoNoCurrent
43598-448-70435980448707 PATCH in 1 CARTON (43598-448-70) / 24 h in 1 PATCH7 patch2019-03-310000-00-00NoNoCurrent
43598-448-744359804487414 PATCH in 1 CARTON (43598-448-74) / 24 h in 1 PATCH14 patch2019-03-310000-00-00NoNoCurrent