What is NDC 43598-487?

43598-487 is the product NDC for Nicotine Polacrilex, Nicotine 4 mg/1 lozenge, listed with the FDA by Dr. Reddy's Laboratories Inc.. It has 19 package NDCs, shown above in 10- and 11-digit form.

Dr. Reddy's Laboratories Inc., NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Nicotine Polacrilex?

46 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nicotine Polacrilex NDC 43598-487 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-487Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0487Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
43598-487-12	4359804871243598048712	5 BOTTLE in 1 CARTON (43598-487-12) / 24 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-13	4359804871343598048713	5 BOTTLE in 1 CARTON (43598-487-13) / 27 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-14	4359804871443598048714	6 BOTTLE in 1 CARTON (43598-487-14) / 24 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-16	4359804871643598048716	6 BOTTLE in 1 CARTON (43598-487-16) / 27 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-17	4359804871743598048717	7 BOTTLE in 1 CARTON (43598-487-17) / 24 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-18	4359804871843598048718	7 BOTTLE in 1 CARTON (43598-487-18) / 27 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-19	4359804871943598048719	8 BOTTLE in 1 CARTON (43598-487-19) / 24 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-22	4359804872243598048722	10 BOTTLE in 1 CARTON (43598-487-22) / 24 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-23	4359804872343598048723	8 BOTTLE in 1 CARTON (43598-487-23) / 27 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-24	4359804872443598048724	1 BOTTLE in 1 CARTON (43598-487-24) / 24 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-27	4359804872743598048727	1 BOTTLE in 1 CARTON (43598-487-27) / 27 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-29	4359804872943598048729	10 BOTTLE in 1 CARTON (43598-487-29) / 27 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-48	4359804874843598048748	2 BOTTLE in 1 CARTON (43598-487-48) / 24 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-54	4359804875443598048754	2 BOTTLE in 1 CARTON (43598-487-54) / 27 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-72	4359804877243598048772	3 BOTTLE in 1 CARTON (43598-487-72) / 24 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-73	4359804877343598048773	7 BOTTLE in 1 CARTON (43598-487-73) / 24 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-74	4359804877443598048774	7 BOTTLE in 1 CARTON (43598-487-74) / 27 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-81	4359804878143598048781	3 BOTTLE in 1 CARTON (43598-487-81) / 27 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-96	4359804879643598048796	4 BOTTLE in 1 CARTON (43598-487-96) / 24 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Nicotine Polacrilex
Generic name (nonproprietary): nicotine polacrilex
Active ingredients: Nicotine — 4 mg/1
Dosage form: Lozenge
Route: Oral
Labeler: Dr. Reddy's Laboratories Inc.NDC labeler code 43598
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212796
Marketing start: Jun 9, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Nicotine (Chemical structure)
Identifiers: Product ID 43598-487_8ede5665-4151-40ed-617b-566b9b565019SPL ID 8ede5665-4151-40ed-617b-566b9b565019SPL set ID b0fdb36d-4cf5-8a91-3da1-90e3587450f9RxCUI 359817, 359818UNII 6M3C89ZY6R
Pharmacologic class: Cholinergic Nicotinic Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N443598048712 followed by a unit qualifier and the quantity

Package 43598-0487-12. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jul 9, 2026.

Indications (excerpt from the label)

Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43598-487

What is NDC 43598-487?: 43598-487 is the product NDC for Nicotine Polacrilex, Nicotine 4 mg/1 lozenge, listed with the FDA by Dr. Reddy's Laboratories Inc.. It has 19 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nicotine Polacrilex.
What is the active ingredient?: Nicotine.
Who is the labeler?: Dr. Reddy's Laboratories Inc., NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nicotine Polacrilex?: 46 other product NDCs are listed under this name. See all Nicotine Polacrilex NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Nicotine Polacrilex NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Nicotine Polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	Lucy Goods, Inc.	72224-924	72224-0924-10
Nicotine Polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	Lucy Goods, Inc.	72224-925	72224-0925-10
Nicotine Polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	Lucy Goods, Inc.	72224-927	72224-0927-10
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Lucy Goods, Inc.	72224-933	72224-0933-10
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-976	55910-0976-20
Nicotine Polacrilex	Nicotine 2 mg/1	Gum, ChewingOral	Quitine LLC	84720-927	84720-0927-03
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Quitine LLC	84720-933	84720-0933-03
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-796	55910-0796-20
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-933	55910-0933-10
Nicotine Polacrilex	Nicotine 4 mg/1	Gum, ChewingOral	A-S Medication Solutions	50090-8146	50090-8146-00

All 47 Nicotine Polacrilex NDCs

Other NDCs under ANDA 212796

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 212796
Product	Strength	Form · route	Labeler	Product NDC
Habitrol Nicotine Polacrilex Lozenge Mintnicotine polacrilex lozenge 2 mg	Nicotine 2 mg/1	LozengeOral	Dr. Reddy's Laboratories Inc.	43598-986
Habitrol Nicotine Polacrilex Lozenge Mintnicotine polacrilex lozenge 4 mg	Nicotine 4 mg/1	LozengeOral	Dr. Reddy's Laboratories Inc.	43598-987
Nicotine Polacrilex	Nicotine 2 mg/1	LozengeOral	Bryant Ranch Prepack	72162-2266
Nicotine Polacrilex	Nicotine 4 mg/1	LozengeOral	Bryant Ranch Prepack	72162-2267