NDC codes

FDA NDC Directory
Product NDC (as listed)59651-297Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0297Add 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
59651-297-015965102970159651029701100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-297-01)Marketed from Jul 19, 2021

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 — 90 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 59651
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213361
Marketing start
Listing expires
Other FDA classes
Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
Identifiers
Product ID 59651-297_4d72a04e-43a6-4fa4-bd1c-1360c4539d71SPL ID 4d72a04e-43a6-4fa4-bd1c-1360c4539d71SPL set ID eb70b7ff-f9f0-41d0-901a-f4c04ae9ed46RxCUI 198034, 198035, 198036UNII 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

N459651029701 followed by a unit qualifier and the quantity

Package 59651-0297-01. 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)

INDICATION AND USAGE Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-297

What is NDC 59651-297?
59651-297 is the product NDC for Nifedipine, Nifedipine 90 mg/1 tablet, extended release, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, 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?
Aurobindo Pharma Limited, NDC labeler code 59651. 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 213361

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

FDA NDC Directory listings under ANDA 213361
ProductStrengthForm · routeLabelerProduct NDC
NifedipineNifedipine 30 mg/1Tablet, Extended releaseOralAurobindo Pharma Limited59651-295
NifedipineNifedipine 60 mg/1Tablet, Extended releaseOralAurobindo Pharma Limited59651-296
NifedipineNifedipine 30 mg/1Tablet, Extended releaseOralRedpharm Drug67296-2170
NifedipineNifedipine 30 mg/1Tablet, Extended releaseOralNuCare Pharmaceuticals,Inc.68071-2838
NifedipineNifedipine 30 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-2534
NifedipineNifedipine 60 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-2535
NifedipineNifedipine 90 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-2536

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