Nicotrol

Product NDC: 0009-5400
11-digit product format: 000095400
Labeler code: 0009
Product ID: 0009-5400_00c25938-fb91-4e66-ac58-11b6e10d6d3a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nicotine
Dosage form: INHALANT
Route: RESPIRATORY (INHALATION)
Labeler: Pharmacia & Upjohn Company LLC
Application: NDA020714
Marketing category: NDA
Marketing start: 1997-05-02
Marketing end: 0000-00-00
Substance: NICOTINE
Active strength: 4 mg/1
Pharmacologic classes: Cholinergic Nicotinic Agonist [EPC],Nicotine [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0009-5400		D	Discontinued by firm		2026-08-17
excluded package	package	0009-5400	0009-5400-01	D	Discontinued by firm		2026-08-17

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020714-001	NICOTROL	NICOTINE	4MG/CARTRIDGE	INHALANT / ORAL		RLD	1997-05-02

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD	1997-05-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD	1997-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD	1997-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD	1997-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD	1997-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD	1997-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD	1997-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD	1997-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD	1997-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD	1997-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020714-001	NICOTROL	4MG/CARTRIDGE	INHALANT / ORAL	RLD, RS	1997-05-02	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0009-5400-01	EA - Each	0009-5400	11e8e0ac-de30-488e-bbde-555181d79d43	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	NICOTROL (NICOTINE) INHALANT [PHARMACIA AND UPJOHN COMPANY]	4
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	NICOTROL (NICOTINE) INHALANT [PHARMACIA AND UPJOHN COMPANY]	4
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	NICOTROL (NICOTINE) INHALANT [PHARMACIA AND UPJOHN COMPANY]	4
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	NICOTROL (NICOTINE) INHALANT [PHYSICIANS TOTAL CARE, INC.]	1
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	NICOTROL (NICOTINE) INHALANT [PHYSICIANS TOTAL CARE, INC.]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	NICOTROL (NICOTINE) INHALANT [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0009-5400	NICOTROL (NICOTINE) INHALANT [PHARMACIA & UPJOHN COMPANY LLC]	12	Legacy NDC	20240814_62245d7d-b50d-48d9-9f03-071c61620ccf.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6M3C89ZY6R	NICOTINE	54-11-5	NICOTINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
250983	nicotine 4 MG Inhalation Solution	PSN	f32f9c92-cbb4-483b-9e70-0b6e4567824f	1
1046920	Nicotrol 4 MG Inhalation Solution	PSN	f32f9c92-cbb4-483b-9e70-0b6e4567824f	1
1046920	nicotine 4 MG Inhalation Solution [Nicotrol]	SBD	f32f9c92-cbb4-483b-9e70-0b6e4567824f	1
250983	nicotine 4 MG Inhalation Solution	SCD	f32f9c92-cbb4-483b-9e70-0b6e4567824f	1
1046920	Nicotrol 4 MG Inhalation Solution	SY	f32f9c92-cbb4-483b-9e70-0b6e4567824f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0009-5400-01	00009540001	28 TRAY in 1 CARTON (0009-5400-01) > 6 CARTRIDGE in 1 TRAY > 1 INHALANT in 1 CARTRIDGE	28 tray	1997-05-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nicotrol	Pharmacia & Upjohn Company LLC	2024-08-09	HUMAN PRESCRIPTION DRUG LABEL	12
NICOTROL	Physicians Total Care, Inc.	2009-12-10	HUMAN PRESCRIPTION DRUG LABEL	1