Habitrol Lozenge

Product NDC: 43598-982
Requested package NDC: 43598-982-13
11-digit product format: 435980982
Labeler code: 43598
Product ID: 43598-982_a6f5eb6e-b06d-71a5-4446-eab7e7372a17
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: LOZENGE
Route: ORAL
Labeler: Dr. Reddy's Laboratories Inc.
Application: ANDA212983
Marketing category: ANDA
Marketing start: 2022-04-01
Substance: NICOTINE
Active strength: 2 mg/1
Pharmacologic classes: Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212983-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2020-02-21
A212983-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL			2020-02-21

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 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A212983-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212983-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212983-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212983-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212983-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212983-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212983-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212983-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212983-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212983-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212983-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212983-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212983-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212983-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212983-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212983-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212983-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212983-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212983-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212983-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212983-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212983-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212983-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212983-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212983-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212983-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212983-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212983-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212983-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212983-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212983-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212983-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212983-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212983-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212983-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212983-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212983-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212983-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212983-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212983-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-02-21	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Habitrol Lozenge
Brand name suffix: Original Flavor
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NICOTINE	2 mg/1

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
359817	Internal RxNorm lookup
359818	Internal RxNorm lookup
2548896	Internal RxNorm lookup
2548898	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
87714b79-05b3-f3c2-6505-5923e4f48871	Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
43598-982-13	Drug Facts
43598-982-13	Drug Facts
43598-982-27	Drug Facts
43598-982-27	Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-982	HABITROL LOZENGE ORIGINAL FLAVOR (NICOTINE POLACRILEX) LOZENGE [DR. REDDY'S LABORATORIES INC.]	5	Current NDC, Legacy NDC	20240706_87714b79-05b3-f3c2-6505-5923e4f48871.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine Polacrilex	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	003b863c-06b0-715d-ccc2-b7da4deac621	2026-07-09	Warnings	Exact identifier application applno (ANDA): 212983 application number: ANDA212983
Habitrol Lozenge Original Flavor	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	87714b79-05b3-f3c2-6505-5923e4f48871	2026-07-09	Warnings	Exact identifier application applno (ANDA): 212983 application number: ANDA212983 ndc (package): 43598-982-13 ndc (product): 43598-982 ndc11 (package): 43598098213

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
2548896	Habitrol 2 MG Oral Lozenge	PSN	87714b79-05b3-f3c2-6505-5923e4f48871	5
2548898	Habitrol 4 MG Oral Lozenge	PSN	87714b79-05b3-f3c2-6505-5923e4f48871	5
359817	nicotine 2 MG Oral Lozenge	PSN	87714b79-05b3-f3c2-6505-5923e4f48871	5
359818	nicotine 4 MG Oral Lozenge	PSN	87714b79-05b3-f3c2-6505-5923e4f48871	5
2548896	nicotine 2 MG Oral Lozenge [Habitrol]	SBD	87714b79-05b3-f3c2-6505-5923e4f48871	5
2548898	nicotine 4 MG Oral Lozenge [Habitrol]	SBD	87714b79-05b3-f3c2-6505-5923e4f48871	5
359817	nicotine 2 MG Oral Lozenge	SCD	87714b79-05b3-f3c2-6505-5923e4f48871	5
359818	nicotine 4 MG Oral Lozenge	SCD	87714b79-05b3-f3c2-6505-5923e4f48871	5
2548896	Habitrol 2 MG Oral Lozenge	SY	87714b79-05b3-f3c2-6505-5923e4f48871	5
2548898	Habitrol 4 MG Oral Lozenge	SY	87714b79-05b3-f3c2-6505-5923e4f48871	5
359817	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral Lozenge	SY	87714b79-05b3-f3c2-6505-5923e4f48871	5
359817	nicotine 2 MG Troche	SY	87714b79-05b3-f3c2-6505-5923e4f48871	5
359818	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral Lozenge	SY	87714b79-05b3-f3c2-6505-5923e4f48871	5
359818	nicotine 4 MG Troche	SY	87714b79-05b3-f3c2-6505-5923e4f48871	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-982-13	43598098213	5 BOTTLE in 1 CARTON (43598-982-13) / 27 LOZENGE in 1 BOTTLE	5 bottle	2022-04-01	0000-00-00	No	No	Current