Over-the-counter drug · NDA

Nicotine transdermal system (Nicotine) NDC 43598-445

Kit · Transdermal · Dr. Reddys Laboratories Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)43598-445Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43598-0445Add 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
43598-445-56435980445564359804455656 PATCH in 1 CARTON (43598-445-56) / 1 KIT in 1 PATCHMarketed from May 14, 2015

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 systemSuffix: transdermal system
Generic name (nonproprietary)
nicotine
Dosage form
Kit
Route
Transdermal
Labeler
Dr. Reddys Laboratories Inc.NDC labeler code 43598
Product type
Over-the-counter drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020076
Marketing start
Listing expires
Identifiers
Product ID 43598-445_8dd0ce2f-82c4-2685-3981-fa22b64b3208SPL ID 8dd0ce2f-82c4-2685-3981-fa22b64b3208SPL set ID e2391b29-9bac-fc09-f2a5-a3370bc4e2c3RxCUI 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

N443598044556 followed by a unit qualifier and the quantity

Package 43598-0445-56. 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 43598-445

What is NDC 43598-445?
43598-445 is the product NDC for Nicotine transdermal system (nicotine) kit, listed with the FDA by Dr. Reddys Laboratories Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nicotine transdermal system (Nicotine).
Who is the labeler?
Dr. Reddys 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?
42 other product NDCs are listed under this name. See all Nicotine transdermal system 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Nicotine Transdermal SystemNicotine 7 mg/24hPatchTransdermalIngenus Pharmaceuticals, LLC50742-66850742-0668-0750742-0668-14
Nicotine Transdermal SystemNicotine 14 mg/24hPatchTransdermalIngenus Pharmaceuticals, LLC50742-66950742-0669-0750742-0669-1450742-0669-28
Nicotine Transdermal SystemNicotine 21 mg/24hPatchTransdermalIngenus Pharmaceuticals, LLC50742-67050742-0670-0750742-0670-1450742-0670-28
Nicotine Transdermal SystemNicotine 7 mg/24hPatchTransdermalQuitine LLC84720-12084720-0120-14
Nicotine Transdermal SystemNicotine 14 mg/24hPatchTransdermalQuitine LLC84720-12184720-0121-14
Nicotine Transdermal SystemNicotine 21 mg/24hPatchTransdermalQuitine LLC84720-12284720-0122-1484720-0122-28
Nicotine Transdermal SystemNicotine 7 mg/24hPatchTransdermalAveva Drug Delivery Systems, Inc.3215-012003215-0120-14
Nicotine Transdermal SystemNicotine 14 mg/24hPatchTransdermalAveva Drug Delivery Systems, Inc.3215-012103215-0121-14
Nicotine Transdermal SystemNicotine 21 mg/24hPatchTransdermalAveva Drug Delivery Systems, Inc.3215-012203215-0122-14
Nicotine Transdermal SystemnicotineNicotine 7 mg/24hFilm, Extended releaseTransdermalEXELAN PHARMACEUTICALS, INC.76282-78176282-0781-40

All 43 Nicotine transdermal system 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 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
Nicotine transdermal system step 1nicotineNicotine 21 mg/24hPatch, Extended releaseTransdermalWalgreens Company0363-0455

Showing 20 of 39.

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