Prescription drug · ANDA

Nifedipine NDC 71205-963

Nifedipine 30 mg/1 · Tablet, Extended release · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)71205-963Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0963Add 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
71205-963-007120509630071205096300100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-963-00)Marketed from Jun 9, 2020
71205-963-30712050963307120509633030 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-963-30)Marketed from Oct 6, 2020
71205-963-60712050963607120509636060 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-963-60)Marketed from Oct 6, 2020
71205-963-647120509636471205096364240 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-963-64)Marketed from Oct 6, 2020
71205-963-677120509636771205096367270 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-963-67)Marketed from Oct 6, 2020
71205-963-727120509637271205096372120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-963-72)Marketed from Oct 6, 2020
71205-963-787120509637871205096378180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-963-78)Marketed from Oct 6, 2020
71205-963-90712050963907120509639090 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-963-90)Marketed from Oct 6, 2020
71205-963-967120509639671205096396300 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-963-96)Marketed from Jun 9, 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 — 30 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 71205
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 71205-963_ba67d6b0-f638-4264-9bd4-1557223abe83SPL ID ba67d6b0-f638-4264-9bd4-1557223abe83SPL set ID d428aa4d-4cc0-4b1e-b9f6-40ae65a735d6RxCUI 1812011, 1812013, 1812015UNII I9ZF7L6G2LUPC 0371205963644, 0371205964009, 0371205965648
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

N471205096300 followed by a unit qualifier and the quantity

Package 71205-0963-00. 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)

About NDC 71205-963

What is NDC 71205-963?
71205-963 is the product NDC for Nifedipine, Nifedipine 30 mg/1 tablet, extended release, listed with the FDA by Proficient Rx LP. It has 9 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nifedipine.
What is the active ingredient?
Nifedipine.
Who is the labeler?
Proficient Rx LP, NDC labeler code 71205. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nifedipine?
127 other product NDCs are listed under this name. See all Nifedipine 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 Nifedipine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
NifedipineNifedipine 30 mg/1Tablet, Film coated, Extended releaseOralCoupler LLC67046-026067046-0260-03
NifedipineNifedipine 10 mg/1CapsuleOralREMEDYREPACK INC.70518-462570518-4625-00
NifedipineNifedipine 10 mg/1CapsuleOralCardinal Health 107, LLC55154-019655154-0196-00
NifedipineNifedipine 90 mg/1Tablet, Film coated, Extended releaseOralSt. Mary's Medical Park Pharmacy60760-86260760-0862-90
NifedipineNifedipine 60 mg/1Tablet, Film coated, Extended releaseOralSt. Mary's Medical Park Pharmacy60760-85960760-0859-90
NifedipineNifedipine 60 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-38651655-0386-52
NifedipineNifedipine 30 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-59351655-0593-26
NifedipineNifedipine 30 mg/1Tablet, Extended releaseOralAlembic Pharmaceuticals Limited46708-73246708-0732-3146708-0732-6346708-0732-91
NifedipineNifedipine 60 mg/1Tablet, Extended releaseOralAlembic Pharmaceuticals Limited46708-73346708-0733-3146708-0733-63
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralAlembic Pharmaceuticals Limited46708-73446708-0734-31

All 128 Nifedipine NDCs

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 60 mg/1Tablet, Extended releaseOralProficient Rx LP71205-412
NifedipineNifedipine 60 mg/1Tablet, Extended releaseOralUpsher-Smith Laboratories, LLC24979-010
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralUpsher-Smith Laboratories, LLC24979-009
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 90 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-738
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralNuCare Pharmaceuticals,Inc.68071-4097
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-9651
NifedipineNifedipine 30 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-290
NifedipineNifedipine 30 mg/1Tablet, Film coated, Extended releaseOralNorthwind Health Company, LLC51655-990
NifedipineNifedipine 30 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-1277
NifedipineNifedipine 30 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.60429-047
NifedipineNifedipine 60 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.60429-048
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralGolden State Medical Supply, Inc.60429-049
NifedipineNifedipine 30 mg/1Tablet, Film coated, Extended releaseOralMajor Pharmaceuticals0904-7208
NifedipineNifedipine 60 mg/1Tablet, Extended releaseOralProficient Rx LP71205-964
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralProficient Rx LP71205-965

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