Over-the-counter drug · NDA

Nicotine transdermal system step 1 (Nicotine) NDC 43598-448

Nicotine 21 mg/24h · Patch, Extended release · Transdermal · Dr. Reddy's Laboratories Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)43598-448Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43598-0448Add 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
43598-448-28435980448284359804482828 PATCH in 1 CARTON (43598-448-28) / 24 h in 1 PATCHMarketed from Mar 31, 2019
43598-448-7043598044870435980448707 PATCH in 1 CARTON (43598-448-70) / 24 h in 1 PATCHMarketed from Mar 31, 2019
43598-448-74435980448744359804487414 PATCH in 1 CARTON (43598-448-74) / 24 h in 1 PATCHMarketed from Mar 31, 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)
Nicotine transdermal system step 1Suffix: transdermal system step 1
Generic name (nonproprietary)
nicotine
Active ingredients
Nicotine — 21 mg/24h
Dosage form
Patch, Extended release
Route
Transdermal
Labeler
Dr. Reddy's Laboratories Inc.NDC labeler code 43598
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020076
Marketing start
Listing expires
Other FDA classes
Nicotine (Chemical structure)
Identifiers
Product ID 43598-448_15710e2c-e365-1726-06de-fb172f976a3bSPL ID 15710e2c-e365-1726-06de-fb172f976a3bSPL set ID 3a68eb70-0548-fa6f-8b1c-375e8799f24fRxCUI 198029, 198030, 198031UNII 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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N443598044828 followed by a unit qualifier and the quantity

Package 43598-0448-28. 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 43598-448

What is NDC 43598-448?
43598-448 is the product NDC for Nicotine transdermal system step 1, Nicotine 21 mg/24h patch, extended release, listed with the FDA by Dr. Reddy's Laboratories Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nicotine transdermal system step 1 (Nicotine).
What is the active ingredient?
Nicotine.
Who is the labeler?
Dr. Reddy's Laboratories Inc., NDC labeler code 43598. 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 system step 1?
12 other product NDCs are listed under this name. See all Nicotine transdermal system step 1 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 Nicotine transdermal system step 1 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Nicotine Transdermal System step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalTopco Associates LLC76162-74276162-0742-14
Nicotine Transdermal System step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalAmerisourceBergen Drug Corporation46122-83346122-0833-4546122-0833-7546122-0833-76
Nicotine Transdermal System step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalCARDINAL HEALTH 110, LLC. DBA LEADER70000-076270000-0762-0170000-0762-02
Nicotine transdermal system step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalChain Drug Marketing Association INC63868-73563868-0735-14
Nicotine transdermal system step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalDOLGENCORP, LLC55910-31355910-0313-02
Nicotine transdermal system step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalRugby Laboratories0536-110800536-1108-88
Nicotine transdermal system step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalStrategic Sourcing Services LLC70677-126670677-1266-0170677-1266-02
Nicotine transdermal system step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalWalgreens Company0363-045500363-0455-7000363-0455-74
Nicotine transdermal system step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalThe Kroger Co.59450-00359450-0003-74
Nicotine transdermal system step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalCVS Pharmacy59779-44859779-0448-0259779-0448-7059779-0448-74

All 13 Nicotine transdermal system step 1 NDCs

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 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
Nicotine transdermal system step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalWalgreens Company0363-0455

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