Over-the-counter drug · ANDA

Nicotine Polacrilex NDC 43598-487

Nicotine 4 mg/1 · Lozenge · Oral · Dr. Reddy's Laboratories Inc.

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 NDC11-digit (billing)PackageCopy
43598-487-12435980487125 BOTTLE in 1 CARTON (43598-487-12) / 24 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-13435980487135 BOTTLE in 1 CARTON (43598-487-13) / 27 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-14435980487146 BOTTLE in 1 CARTON (43598-487-14) / 24 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-16435980487166 BOTTLE in 1 CARTON (43598-487-16) / 27 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-17435980487177 BOTTLE in 1 CARTON (43598-487-17) / 24 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-18435980487187 BOTTLE in 1 CARTON (43598-487-18) / 27 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-19435980487198 BOTTLE in 1 CARTON (43598-487-19) / 24 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-224359804872210 BOTTLE in 1 CARTON (43598-487-22) / 24 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-23435980487238 BOTTLE in 1 CARTON (43598-487-23) / 27 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-24435980487241 BOTTLE in 1 CARTON (43598-487-24) / 24 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-27435980487271 BOTTLE in 1 CARTON (43598-487-27) / 27 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-294359804872910 BOTTLE in 1 CARTON (43598-487-29) / 27 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-48435980487482 BOTTLE in 1 CARTON (43598-487-48) / 24 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-54435980487542 BOTTLE in 1 CARTON (43598-487-54) / 27 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-72435980487723 BOTTLE in 1 CARTON (43598-487-72) / 24 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-73435980487737 BOTTLE in 1 CARTON (43598-487-73) / 24 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-74435980487747 BOTTLE in 1 CARTON (43598-487-74) / 27 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-81435980487813 BOTTLE in 1 CARTON (43598-487-81) / 27 LOZENGE in 1 BOTTLEMarketed from Jun 9, 2020
43598-487-96435980487964 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
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212796
Marketing start
Listing expires
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 .

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)

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
ProductStrengthForm · routeLabelerProduct NDC
Habitrol Nicotine Polacrilex Lozenge Mintnicotine polacrilex lozenge 2 mgNicotine 2 mg/1LozengeOralDr. Reddy's Laboratories Inc.43598-986
Habitrol Nicotine Polacrilex Lozenge Mintnicotine polacrilex lozenge 4 mgNicotine 4 mg/1LozengeOralDr. Reddy's Laboratories Inc.43598-987
Nicotine PolacrilexNicotine 2 mg/1LozengeOralDr. Reddy's Laboratories Inc.43598-486
Nicotine PolacrilexNicotine 2 mg/1LozengeOralBryant Ranch Prepack72162-2266
Nicotine PolacrilexNicotine 4 mg/1LozengeOralBryant Ranch Prepack72162-2267

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Nicotine Polacrilex NDC 43598-487 | Med-Code