Over-the-counter drug · ANDA

equate nicotine (Nicotine polacrilex) NDC 49035-873

Nicotine 4 mg/1 · Lozenge · Oral · Wal-Mart Stores Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)49035-873Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49035-0873Add 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
49035-873-0349035087303490350873031 CONTAINER in 1 CARTON (49035-873-03) / 24 LOZENGE in 1 CONTAINERMarketed from Oct 10, 2011
49035-873-1049035087310490350873104 CONTAINER in 1 CARTON (49035-873-10) / 27 LOZENGE in 1 CONTAINERMarketed from May 25, 2010
49035-873-1149035087311490350873117 CONTAINER in 1 CARTON (49035-873-11) / 24 LOZENGE in 1 CONTAINERMarketed from Feb 27, 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)
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 077007
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 49035-873_c70c1757-ce45-46d0-acc5-1d8d179395acSPL ID c70c1757-ce45-46d0-acc5-1d8d179395acSPL set ID 53387dd6-28c0-412d-bc74-4d323c8d5e11RxCUI 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

N449035087303 followed by a unit qualifier and the quantity

Package 49035-0873-03. 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 49035-873

What is NDC 49035-873?
49035-873 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 3 package NDCs, 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 077007

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

FDA NDC Directory listings under ANDA 077007
ProductStrengthForm · routeLabelerProduct NDC
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-344
basic care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmazon.com Services LLC72288-492
basic care nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-509
basic care nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmazon.com Services LLC72288-873
berkley and jensen nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralBJWC68391-344
berkley and jensen nicotine polacrilexnicotine polacrilexNicotine 4 mg/1LozengeOralBJWC68391-873
care one nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralAmerican Sales Company41520-873
careone nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralAmerican Sales Company41520-701
Equate Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWal-Mart Stores Inc49035-998
equate nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWALMART INC.79903-182
Equate Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWALMART INC.79903-353
Equate Nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralWALMART INC.79903-354
euqate nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralWALMART INC.79903-101
exchange select nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralArmy & Air Force Exchange Service55301-617
exchange select nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralArmy & Air Force Exchange Service55301-873
foster and thrive nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralStrategic Sourcing Services LLC70677-1176
foster and thrive nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralStrategic Sourcing Services LLC70677-1177
Good Sense Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralL. Perrigo Company0113-0344
good sense nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralL. Perrigo Company0113-0873
Good Sense Nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralL. Perrigo Company0113-2502

Showing 20 of 39.

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