What is NDC 68382-687?

68382-687 is the product NDC for Nifedipine, Nifedipine 90 mg/1 tablet, extended release, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Zydus Pharmaceuticals (USA) Inc., NDC labeler code 68382. 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 68382-687 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-687Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0687Add 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
68382-687-01	6838206870168382068701	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-687-01)Marketed from Feb 2, 2018
68382-687-10	6838206871068382068710	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-687-10)Marketed from Feb 2, 2018
68382-687-95	6838206879568382068795	300 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-687-95)Marketed from Feb 2, 2018

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: Zydus Pharmaceuticals (USA) Inc.NDC labeler code 68382
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210012
Marketing start: Feb 2, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
Identifiers: Product ID 68382-687_c0025ef1-99d7-4b31-9d99-4be010b2b9fbSPL ID c0025ef1-99d7-4b31-9d99-4be010b2b9fbSPL set ID 657221d5-9eb8-42f9-8cdc-39cefc386f51RxCUI 1812011, 1812013, 1812015UNII I9ZF7L6G2LUPC 0368382687012, 0368382686015, 0368382685018
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

N468382068701 followed by a unit qualifier and the quantity

Package 68382-0687-01. 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 Dec 11, 2024.

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 68382-687

What is NDC 68382-687?: 68382-687 is the product NDC for Nifedipine, Nifedipine 90 mg/1 tablet, extended release, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. 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 Pharmaceuticals (USA) Inc., NDC labeler code 68382. 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 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
Product	Strength	Form · route	Labeler	Product NDC
Nifedipine	Nifedipine 30 mg/1	Tablet, Extended releaseOral	Zydus Pharmaceuticals (USA) Inc.	68382-685
Nifedipine	Nifedipine 60 mg/1	Tablet, Extended releaseOral	Zydus Pharmaceuticals (USA) Inc.	68382-686
Nifedipine	Nifedipine 30 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	70771-1190
Nifedipine	Nifedipine 60 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	70771-1191
Nifedipine	Nifedipine 90 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	70771-1192