Over-the-counter drug · NDA

Nicotine Transdermal (Nicotine) NDC 11822-3627

Kit · Transdermal · Rite Aid Corporation

NDC codes

FDA NDC Directory
Product NDC (as listed)11822-3627Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11822-3627Add 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
11822-3627-3118223627031182236270356 PATCH in 1 CARTON (11822-3627-3) / 1 KIT in 1 PATCHMarketed from Mar 31, 2021

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 TransdermalSuffix: TRANSDERMAL
Generic name (nonproprietary)
nicotine
Dosage form
Kit
Route
Transdermal
Labeler
Rite Aid CorporationNDC labeler code 11822
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020076
Marketing start
Listing expires
Identifiers
Product ID 11822-3627_cc8505c5-38ba-5bb3-5c4d-0e7a1984eae4SPL ID cc8505c5-38ba-5bb3-5c4d-0e7a1984eae4SPL set ID ae6027da-5c96-ed47-e1ae-e900fc0f72ceRxCUI 198029, 198030, 198031, 892244

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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N411822362703 followed by a unit qualifier and the quantity

Package 11822-3627-03. 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 11822-3627

What is NDC 11822-3627?
11822-3627 is the product NDC for Nicotine Transdermal (nicotine) kit, listed with the FDA by Rite Aid Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nicotine Transdermal (Nicotine).
Who is the labeler?
Rite Aid Corporation, NDC labeler code 11822. 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 Transdermal?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 020076

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

FDA NDC Directory listings under NDA 020076
ProductStrengthForm · routeLabelerProduct NDC
Nicotine transdermal system step 2nicotineNicotine 14 mg/24hPatch, Extended releaseTransdermalRugby Laboratories0536-1107
Nicotine Transdermal SystemnicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalA-S Medication Solutions50090-7936
Nicotine transdermal system step 3nicotineNicotine 7 mg/24hPatch, Extended releaseTransdermalDr. Reddy's Laboratories Inc.43598-446
Nicotine transdermal systemnicotine—KitTransdermalDr. Reddys Laboratories Inc.43598-445
Nicotine transdermal system step 2nicotineNicotine 14 mg/24hPatch, Extended releaseTransdermalDr. Reddy's Laboratories Inc.43598-447
Nicotine transdermal system step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalDr. Reddy's Laboratories Inc.43598-448
Nicotine transdermal system step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalDOLGENCORP, LLC55910-313
Nicotine transdermal system step 3nicotineNicotine 7 mg/24hPatch, Extended releaseTransdermalRugby Laboratories0536-1106
Nicotine Transdermal System step 2nicotineNicotine 14 mg/24hPatch, Extended releaseTransdermalAmerisourceBergen Drug Corporation46122-832
Nicotine Transdermal System step 3nicotineNicotine 7 mg/24hPatch, Extended releaseTransdermalAmerisourceBergen Drug Corporation46122-831
Nicotine Transdermal System step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalAmerisourceBergen Drug Corporation46122-833
Nicotine transdermal system step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalRugby Laboratories0536-1108
nicotine transdermal systemnicotine—KitTransdermalDr. Reddy's Laboratories Inc.55741-449
Habitrol Step 3nicotine transdermal system patchNicotine 7 mg/24hPatch, Extended releaseTransdermalDr. Reddy's Laboratories Inc.55741-446
Habitrol Step 2nicotine transdermal system patchNicotine 14 mg/24hPatch, Extended releaseTransdermalDr. Reddy's Laboratories Inc.55741-447
Habitrol Step 1nicotine transdermal system patchNicotine 21 mg/24hPatch, Extended releaseTransdermalDr. Reddy's Laboratories Inc.55741-448
Nicotine transdermal system step 3nicotineNicotine 7 mg/24hPatch, Extended releaseTransdermalWalgreens Company0363-0451
Nicotine transdermal system step 3nicotineNicotine 7 mg/24hPatch, Extended releaseTransdermalCVS Pharmacy59779-443
Nicotine transdermal system step 2nicotineNicotine 14 mg/24hPatch, Extended releaseTransdermalCVS Pharmacy59779-445
Nicotine transdermal system step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalCVS Pharmacy59779-448

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