Nicotine Polacrilex

Product NDC: 43598-489
Requested package NDC: 43598-489-27
11-digit product format: 435980489
Labeler code: 43598
Product ID: 43598-489_ea14d88d-2ad8-b2e9-bf8f-8a299e66d618
Type: HUMAN OTC DRUG
Nonproprietary name: Nicotine Polacrilex
Dosage form: LOZENGE
Route: ORAL
Labeler: Dr. Reddy's Laboratories Inc.
Application: ANDA213233
Marketing category: ANDA
Marketing start: 2020-10-01
Substance: NICOTINE
Active strength: 4 mg/1
Pharmacologic classes: Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213233-001	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL			2020-08-04
A213233-002	NICOTINE POLACRILEX	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL			2020-08-04

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 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213233-001	NICOTINE POLACRILEX	EQ 2MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213233-002	NICOTINE POLACRILEX	EQ 4MG BASE	TROCHE/LOZENGE / ORAL	2020-08-04	`87673890dc5c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Habitrol Lozenge Cherry	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	5a464242-7d63-141e-808e-c41676cf4b78	2026-07-09	Warnings	Exact identifier application applno (ANDA): 213233 application number: ANDA213233
Nicotine Polacrilex	NICOTINE POLACRILEX	Dr. Reddy's Laboratories Inc.	6b0342dd-120f-a16e-098a-dc45b14d3d3a	2026-07-09	Warnings	Exact identifier application applno (ANDA): 213233 application number: ANDA213233 ndc (package): 43598-489-27 ndc (product): 43598-489 ndc11 (package): 43598048927

Additional Listing Data#

Finished product: Yes
Brand name base: Nicotine Polacrilex
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NICOTINE	4 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
359817	Internal RxNorm lookup
359818	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
6b0342dd-120f-a16e-098a-dc45b14d3d3a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43598-489-10	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-10	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-12	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-12	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-13	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-13	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-14	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-14	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-16	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-16	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-17	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-17	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-18	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-18	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-19	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-19	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-22	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-22	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-23	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-23	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-24	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-24	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-27	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-27	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-29	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-29	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-48	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-48	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-54	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-54	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-72	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-72	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-73	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-73	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-74	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-74	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-81	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-81	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-96	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts
43598-489-96	2024-01-30	C162847	48780-1	1030e365-0e87-111a-e063-dadaa90a10e2	Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-489	NICOTINE POLACRILEX LOZENGE [DR. REDDY'S LABORATORIES INC.]	6	Current NDC, Legacy NDC	20240706_6b0342dd-120f-a16e-098a-dc45b14d3d3a.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
2548896	Habitrol 2 MG Oral Lozenge	PSN	5a464242-7d63-141e-808e-c41676cf4b78	6
2548898	Habitrol 4 MG Oral Lozenge	PSN	5a464242-7d63-141e-808e-c41676cf4b78	6
359817	nicotine 2 MG Oral Lozenge	PSN	6b0342dd-120f-a16e-098a-dc45b14d3d3a	6
359817	nicotine 2 MG Oral Lozenge	PSN	5a464242-7d63-141e-808e-c41676cf4b78	6
359818	nicotine 4 MG Oral Lozenge	PSN	5a464242-7d63-141e-808e-c41676cf4b78	6
359818	nicotine 4 MG Oral Lozenge	PSN	6b0342dd-120f-a16e-098a-dc45b14d3d3a	6
2548896	nicotine 2 MG Oral Lozenge [Habitrol]	SBD	5a464242-7d63-141e-808e-c41676cf4b78	6
2548898	nicotine 4 MG Oral Lozenge [Habitrol]	SBD	5a464242-7d63-141e-808e-c41676cf4b78	6
359817	nicotine 2 MG Oral Lozenge	SCD	5a464242-7d63-141e-808e-c41676cf4b78	6
359817	nicotine 2 MG Oral Lozenge	SCD	6b0342dd-120f-a16e-098a-dc45b14d3d3a	6
359818	nicotine 4 MG Oral Lozenge	SCD	5a464242-7d63-141e-808e-c41676cf4b78	6
359818	nicotine 4 MG Oral Lozenge	SCD	6b0342dd-120f-a16e-098a-dc45b14d3d3a	6
2548896	Habitrol 2 MG Oral Lozenge	SY	5a464242-7d63-141e-808e-c41676cf4b78	6
2548898	Habitrol 4 MG Oral Lozenge	SY	5a464242-7d63-141e-808e-c41676cf4b78	6
359817	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral Lozenge	SY	5a464242-7d63-141e-808e-c41676cf4b78	6
359817	nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral Lozenge	SY	6b0342dd-120f-a16e-098a-dc45b14d3d3a	6
359817	nicotine 2 MG Troche	SY	6b0342dd-120f-a16e-098a-dc45b14d3d3a	6
359817	nicotine 2 MG Troche	SY	5a464242-7d63-141e-808e-c41676cf4b78	6
359818	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral Lozenge	SY	5a464242-7d63-141e-808e-c41676cf4b78	6
359818	nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral Lozenge	SY	6b0342dd-120f-a16e-098a-dc45b14d3d3a	6
359818	nicotine 4 MG Troche	SY	6b0342dd-120f-a16e-098a-dc45b14d3d3a	6
359818	nicotine 4 MG Troche	SY	5a464242-7d63-141e-808e-c41676cf4b78	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-489-27	43598048927	1 BOTTLE in 1 CARTON (43598-489-27) / 27 LOZENGE in 1 BOTTLE	1 bottle	2020-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Dr. Reddy's Laboratories Inc.	2026-07-09	HUMAN OTC DRUG LABEL	7
Drug Facts	Dr. Reddy's Laboratories Inc. \| Quality Packaging Specialists International, LLC	2026-07-09	HUMAN OTC DRUG LABEL	7