Prescription drug · ANDA

Nifedipine NDC 71205-412

Nifedipine 60 mg/1 · Tablet, Extended release · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)71205-412Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0412Add 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
71205-412-307120504123030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-412-30)Marketed from Feb 26, 2020
71205-412-607120504126060 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-412-60)Marketed from Feb 26, 2020
71205-412-907120504129090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-412-90)Marketed from Feb 26, 2020

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, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203126
Marketing start
Listing expires
Other FDA classes
Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
Identifiers
Product ID 71205-412_838d6e8f-37b0-48d3-b701-c4fa32a87b85SPL ID 838d6e8f-37b0-48d3-b701-c4fa32a87b85SPL set ID 838d6e8f-37b0-48d3-b701-c4fa32a87b85RxCUI 1812013UNII I9ZF7L6G2L
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

N471205041230 followed by a unit qualifier and the quantity

Package 71205-0412-30. 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 & 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 comp…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203126

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

FDA NDC Directory listings under ANDA 203126
ProductStrengthForm · routeLabelerProduct NDC
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralUpsher-Smith Laboratories, LLC24979-009
NifedipineNifedipine 60 mg/1Tablet, Extended releaseOralUpsher-Smith Laboratories, LLC24979-010
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralUpsher-Smith Laboratories, LLC24979-009
NifedipineNifedipine 60 mg/1Tablet, Extended releaseOralUpsher-Smith Laboratories, LLC24979-010
NifedipineNifedipine 30 mg/1Tablet, Film coated, Extended releaseOralUpsher-Smith Laboratories, LLC24979-011
NifedipineNifedipine 30 mg/1Tablet, Film coated, Extended releaseOralUpsher-Smith Laboratories, LLC24979-011
NifedipineNifedipine 30 mg/1Tablet, Film coated, Extended releaseOralNorthwind Health Company, LLC51655-990
NifedipineNifedipine 30 mg/1Tablet, Film coated, Extended releaseOralMajor Pharmaceuticals0904-7208
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.60429-049
NifedipineNifedipine 30 mg/1Tablet, Extended releaseOralProficient Rx LP71205-963
NifedipineNifedipine 60 mg/1Tablet, Extended releaseOralProficient Rx LP71205-964
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralProficient Rx LP71205-965
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-9651
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-738
NifedipineNifedipine 60 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.60429-048
NifedipineNifedipine 30 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.60429-047
NifedipineNifedipine 30 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-290
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralNuCare Pharmaceuticals,Inc.68071-4097
NifedipineNifedipine 30 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-1277

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