NDC codes

FDA NDC Directory
Product NDC (as listed)0603-3581Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00603-3581Add 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
0603-3581-210060335812100603358121100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-3581-21)Marketed from Mar 31, 2009
0603-3581-280060335812800603358128500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0603-3581-28)Marketed from Mar 31, 2009

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Felodipine
Generic name (nonproprietary)
felodipine
Active ingredients
Felodipine — 2.5 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Par Health USA, LLCNDC labeler code 0603
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 200815
Marketing start
Marketing end
Other FDA classes
Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
Identifiers
Product ID 0603-3581_02151da2-890e-4f84-94c8-6ce767d9ff12SPL ID 02151da2-890e-4f84-94c8-6ce767d9ff12
Pharmacologic class
Dihydropyridine Calcium Channel Blocker

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

N400603358121 followed by a unit qualifier and the quantity

Package 00603-3581-21. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0603-3581

What is NDC 0603-3581?
0603-3581 is the product NDC for Felodipine, Felodipine 2.5 mg/1 tablet, extended release, listed with the FDA by Par Health USA, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Felodipine.
What is the active ingredient?
Felodipine.
Who is the labeler?
Par Health USA, LLC, NDC labeler code 0603. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Felodipine?
49 other product NDCs are listed under this name. See all Felodipine 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 Felodipine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
FelodipineFelodipine 2.5 mg/1Tablet, Extended releaseOralWestminster Pharmaceuticals, LLC69367-26469367-0264-01
FelodipineFelodipine 5 mg/1Tablet, Extended releaseOralWestminster Pharmaceuticals, LLC69367-26569367-0265-01
FelodipineFelodipine 2.5 mg/1Tablet, Film coatedOralCarlsbad Technology, Inc.61442-43161442-0431-0161442-0431-05
FelodipineFelodipine 5 mg/1Tablet, Film coatedOralCarlsbad Technology, Inc.61442-43261442-0432-0161442-0432-05
FelodipineFelodipine 10 mg/1Tablet, Film coatedOralCarlsbad Technology, Inc.61442-43361442-0433-0161442-0433-05
FelodipineFelodipine 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-201663629-2016-01
FelodipineFelodipine 2.5 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-201763629-2017-01
FelodipineFelodipine 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-201863629-2018-01
FelodipineFelodipine 2.5 mg/1Tablet, Film coatedOralProficient Rx LP71205-92071205-0920-0071205-0920-3071205-0920-55+3 more
FelodipineFelodipine 5 mg/1Tablet, Film coatedOralProficient Rx LP71205-92171205-0921-0071205-0921-3071205-0921-55+3 more

All 50 Felodipine NDCs

Other NDCs under ANDA 200815

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

FDA NDC Directory listings under ANDA 200815
ProductStrengthForm · routeLabelerProduct NDC
FelodipineFelodipine 5 mg/1Tablet, Extended releaseOralPar Health USA, LLC0603-3582
FelodipineFelodipine 10 mg/1Tablet, Film coated, Extended releaseOralPar Health USA, LLC0603-3583
FelodipineFelodipine 10 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack63629-2191
FelodipineFelodipine 5 mg/1Tablet, Extended releaseOralBryant Ranch Prepack63629-2195
FelodipineFelodipine 5 mg/1Tablet, Extended releaseOralBryant Ranch Prepack63629-2196
FelodipineFelodipine 2.5 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-1158
FelodipineFelodipine 10 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack72162-1160

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