NDC codes

FDA NDC Directory
Product NDC (as listed)68682-109Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68682-0109Add 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
68682-109-1068682010910100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-109-10)Marketed from Sep 27, 2000
68682-109-3068682010930300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-109-30)Marketed from Sep 27, 2000

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)
nifedipine
Generic name (nonproprietary)
nifedipine
Active ingredients
Nifedipine — 60 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075289
Marketing start
Listing expires
Other FDA classes
Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
Identifiers
Product ID 68682-109_68cca98c-658a-48b4-9630-478b62b1471eSPL ID 68cca98c-658a-48b4-9630-478b62b1471eSPL set ID c7874606-c71e-424c-b881-38697988e0d0RxCUI 1812011, 1812013UNII I9ZF7L6G2LUPC 0368682108101
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

N468682010910 followed by a unit qualifier and the quantity

Package 68682-0109-10. 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)

INDICATIONS AND USAGE I. Vasospastic Angina Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended-release tablets may also be used where the clinical presentation suggests a possible vasospastic co…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075289

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

FDA NDC Directory listings under ANDA 075289
ProductStrengthForm · routeLabelerProduct NDC
nifedipineNifedipine 30 mg/1Tablet, Film coated, Extended releaseOralOceanside Pharmaceuticals68682-108
nifedipineNifedipine 60 mg/1Tablet, Film coated, Extended releaseOralBryant Ranch Prepack71335-0744

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