NDC codes

FDA NDC Directory
Product NDC (as listed)49035-702Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49035-0702Add 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
49035-702-1049035070210490350702104 CONTAINER in 1 CARTON (49035-702-10) / 27 LOZENGE in 1 CONTAINER (49035-702-09)Marketed from Oct 7, 2016

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)
Equate Nicotine
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine — 4 mg/1
Dosage form
Lozenge
Route
Oral
Labeler
Wal-Mart Stores IncNDC labeler code 49035
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090821
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 49035-702_8038fc3a-3ff9-4ab6-8717-1abfae0518a5SPL ID 8038fc3a-3ff9-4ab6-8717-1abfae0518a5SPL set ID 43a24aa7-ba1c-4c5d-9ec8-ed496e299e00RxCUI 359818UNII 6M3C89ZY6RUPC 0012345678905
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

N449035070210 followed by a unit qualifier and the quantity

Package 49035-0702-10. 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)

About NDC 49035-702

What is NDC 49035-702?
49035-702 is the product NDC for Equate Nicotine (nicotine polacrilex), Nicotine 4 mg/1 lozenge, listed with the FDA by Wal-Mart Stores Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Equate Nicotine (Nicotine Polacrilex).
What is the active ingredient?
Nicotine.
Who is the labeler?
Wal-Mart Stores Inc, NDC labeler code 49035. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Equate Nicotine?
25 other product NDCs are listed under this name. See all Equate Nicotine 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 Equate Nicotine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Equate Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWALMART INC.79903-35479903-0354-2079903-0354-80
Equate Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWALMART INC.79903-35379903-0353-2079903-0353-80
equate nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWALMART INC.79903-18279903-0182-2079903-0182-80
equate nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWALMART INC.79903-10479903-0104-0879903-0104-27
equate nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWALMART INC.79903-16079903-0160-0879903-0160-27
equate nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralWal-Mart Stores Inc49035-41549035-0415-78
equate nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralWal-Mart Stores Inc49035-30949035-0309-78
equate nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWal-Mart Stores Inc49035-79149035-0791-10
Equate nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWal-Mart Stores Inc49035-90049035-0900-10
Equate Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWal-Mart Stores Inc49035-20149035-0201-0949035-0201-10

All 26 Equate Nicotine NDCs

Other NDCs under ANDA 090821

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

FDA NDC Directory listings under ANDA 090821
ProductStrengthForm · routeLabelerProduct NDC
Equate Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWal-Mart Stores Inc49035-201
foster and thrive nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralStrategic Sourcing Services LLC70677-1174
foster and thrive nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralStrategic Sourcing Services LLC70677-1175
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWalgreen Company0363-0201
Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWalgreen Company0363-0424
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralRite Aid Corporation11822-0201
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralRite Aid Corporation11822-0424
nicotinenicotine polarilexNicotine 2 mg/1LozengeOralMeijer Distribution Inc41250-201
Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralMeijer Distribution Inc41250-424
nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralCVS Pharmacy59779-201
nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralCVS Pharmacy59779-424

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