What is NDC 71610-012?

71610-012 is the product NDC for Nifedipine, Nifedipine 60 mg/1 tablet, extended release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nifedipine NDC 71610-012 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-012Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0012Add 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 NDC	11-digit (billing)	Package
71610-012-04	7161000120471610001204	4000 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-04)Marketed from Apr 2, 2024
71610-012-16	7161000121671610001216	6000 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-16)Marketed from Sep 20, 2021
71610-012-60	7161000126071610001260	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-60)Marketed from Nov 15, 2017
71610-012-80	7161000128071610001280	180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-80)Marketed from May 1, 2019

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
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075269
Marketing start: Dec 4, 2000
Listing expires: Dec 31, 2026
Other FDA classes: Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
Identifiers: Product ID 71610-012_15325d8c-d716-9819-e063-6294a90a06d9SPL ID 15325d8c-d716-9819-e063-6294a90a06d9SPL set ID 81e6c8e7-e826-4abb-ad58-1dee62091a66RxCUI 198035UNII 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

N471610001204 followed by a unit qualifier and the quantity

Package 71610-0012-04. 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 Apr 3, 2024.

Indications (excerpt from the label)

INDICATIONS 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 71610-012

What is NDC 71610-012?: 71610-012 is the product NDC for Nifedipine, Nifedipine 60 mg/1 tablet, extended release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Nifedipine	Nifedipine 30 mg/1	Tablet, Film coated, Extended releaseOral	Coupler LLC	67046-0260	67046-0260-03
Nifedipine	Nifedipine 10 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4625	70518-4625-00
Nifedipine	Nifedipine 10 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-0196	55154-0196-00
Nifedipine	Nifedipine 90 mg/1	Tablet, Film coated, Extended releaseOral	St. Mary's Medical Park Pharmacy	60760-862	60760-0862-90
Nifedipine	Nifedipine 60 mg/1	Tablet, Film coated, Extended releaseOral	St. Mary's Medical Park Pharmacy	60760-859	60760-0859-90
Nifedipine	Nifedipine 60 mg/1	Tablet, Extended releaseOral	Northwind Health Company, LLC	51655-386	51655-0386-52
Nifedipine	Nifedipine 30 mg/1	Tablet, Extended releaseOral	Northwind Health Company, LLC	51655-593	51655-0593-26
Nifedipine	Nifedipine 30 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-732	46708-0732-3146708-0732-6346708-0732-91
Nifedipine	Nifedipine 60 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-733	46708-0733-3146708-0733-63
Nifedipine	Nifedipine 90 mg/1	Tablet, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-734	46708-0734-31

All 128 Nifedipine NDCs

Other NDCs under ANDA 075269

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

FDA NDC Directory listings under ANDA 075269
Product	Strength	Form · route	Labeler	Product NDC
Nifedipine	Nifedipine 30 mg/1	Tablet, Extended releaseOral	A-S Medication Solutions	50090-5284
Nifedipine	Nifedipine 30 mg/1	Tablet, Extended releaseOral	Northwind Health Company, LLC	51655-798
Nifedipine	Nifedipine 30 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	63629-9109
Nifedipine	Nifedipine 30 mg/1	Tablet, Extended releaseOral	Oceanside Pharmaceuticals	68682-105
Nifedipine	Nifedipine 60 mg/1	Tablet, Extended releaseOral	Oceanside Pharmaceuticals	68682-106
Nifedipine	Nifedipine 30 mg/1	Tablet, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-144
Nifedipine	Nifedipine 30 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	72162-1887
Nifedipine	Nifedipine 60 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	72162-2260