NDC codes

FDA NDC Directory
Product NDC (as listed)70771-1191Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1191Add 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
70771-1191-070771119100707711191001000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1191-0)Marketed from Feb 2, 2018
70771-1191-17077111910170771119101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1191-1)Marketed from Feb 2, 2018
70771-1191-37077111910370771119103300 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1191-3)Marketed from Feb 2, 2018

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Labeler
Zydus Lifesciences LimitedNDC labeler code 70771
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210012
Marketing start
Listing expires
Other FDA classes
Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
Identifiers
Product ID 70771-1191_b8c99bfa-b2c5-4436-8e84-54348a032311SPL ID b8c99bfa-b2c5-4436-8e84-54348a032311SPL set ID ac3f68b2-29b5-45c1-b6a2-54704dc3143eRxCUI 1812011, 1812013, 1812015UNII I9ZF7L6G2LUPC 0370771119011, 0370771119110, 0370771119219
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

N470771119100 followed by a unit qualifier and the quantity

Package 70771-1191-00. 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 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)

About NDC 70771-1191

What is NDC 70771-1191?
70771-1191 is the product NDC for Nifedipine, Nifedipine 60 mg/1 tablet, extended release, listed with the FDA by Zydus Lifesciences Limited. It has 3 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?
Zydus Lifesciences Limited, NDC labeler code 70771. 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 210012

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

FDA NDC Directory listings under ANDA 210012
ProductStrengthForm · routeLabelerProduct NDC
NifedipineNifedipine 30 mg/1Tablet, Extended releaseOralZydus Pharmaceuticals (USA) Inc.68382-685
NifedipineNifedipine 60 mg/1Tablet, Extended releaseOralZydus Pharmaceuticals (USA) Inc.68382-686
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralZydus Pharmaceuticals (USA) Inc.68382-687
NifedipineNifedipine 30 mg/1Tablet, Extended releaseOralZydus Lifesciences Limited70771-1190
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralZydus Lifesciences Limited70771-1192

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