Over-the-counter drug · ANDA

signature care nicotine (Nicotine polacrilex) NDC 21130-820

Nicotine 4 mg/1 · Gum, Chewing · Oral · Safeway

NDC codes

FDA NDC Directory
Product NDC (as listed)21130-820Labeler and product segments. Claims need a package NDC.
Product NDC at billing width21130-0820Add 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
21130-820-7821130082078100 BLISTER PACK in 1 CARTON (21130-820-78) / 1 GUM, CHEWING in 1 BLISTER PACKMarketed from Sep 10, 2019

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)
signature care nicotine
Generic name (nonproprietary)
nicotine polacrilex
Active ingredients
Nicotine — 4 mg/1
Dosage form
Gum, Chewing
Route
Oral
Labeler
SafewayNDC labeler code 21130
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206393
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 21130-820_0847a4d4-6544-490d-9d29-63ead56038a6SPL ID 0847a4d4-6544-490d-9d29-63ead56038a6SPL set ID bcf4407a-b0ff-40bb-9bb9-6c36bdd525fcRxCUI 311975UNII 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

N421130082078 followed by a unit qualifier and the quantity

Package 21130-0820-78. 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 21130-820

What is NDC 21130-820?
21130-820 is the product NDC for signature care nicotine (nicotine polacrilex), Nicotine 4 mg/1 gum, chewing, listed with the FDA by Safeway. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
signature care nicotine (Nicotine polacrilex).
What is the active ingredient?
Nicotine.
Who is the labeler?
Safeway, NDC labeler code 21130. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for signature care nicotine?
7 other product NDCs are listed under this name. See all signature care 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 signature care nicotine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
signature care nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralSafeway21130-26921130-0269-78
signature care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralSafeway21130-17221130-0172-02
signature care nicotinenicotine polacrilexNicotine 4 mg/1LozengeOralSafeway21130-18521130-0185-02
signature care nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralSafeway21130-52221130-0522-25
signature care nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralSafeway21130-17321130-0173-78
signature care nicotinenicotine polacrilexNicotine 2 mg/1Gum, ChewingOralSafeway21130-18621130-0186-78
signature care nicotinenicotine polacrilexNicotine 2 mg/1LozengeOralSafeway21130-70021130-0700-05

Other NDCs under ANDA 206393

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

FDA NDC Directory listings under ANDA 206393
ProductStrengthForm · routeLabelerProduct NDC
Basic Care Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-003
basic care nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-577
basic care nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmazon.com Services LLC72288-693
Berkley and Jensen Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralBJWC68391-309
Blipnicotine polacrilexNicotine 4 mg/1Gum, ChewingOralBlip Products, Inc.82966-309
blipnicotine polacrilexNicotine 4 mg/1Gum, ChewingOralBlip Products, Inc.82966-971
careone nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralAmerican Sales Company41520-843
Coated Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralPublix Super Markets Inc56062-369
equate nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralWal-Mart Stores Inc49035-309
foster and thrive nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralStrategic Sourcing Services LLC70677-1193
Good Sense Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralL. Perrigo Company0113-0053
Good Sense Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralL. Perrigo Company0113-4111
good sense nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralL. Perrigo Company0113-8600
good sense nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralA-S Medication Solutions50090-6695
kirkland signature quit 4nicotine polacrilexNicotine 4 mg/1Gum, ChewingOralCostco Wholesale Company63981-309
members mark nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralSam's West Inc68196-309
Members Mark Nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralSam's West Inc68196-971
nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralWalgreen Company0363-2309
nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralWalgreen Company0363-7103
nicotinenicotine polacrilexNicotine 4 mg/1Gum, ChewingOralWalgreen Company0363-7971

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