What is NDC 68382-688?

68382-688 is the product NDC for Nifedipine, Nifedipine 30 mg/1 tablet, extended release, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. It has 6 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 68382-688 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-688Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0688Add 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
68382-688-01	6838206880168382068801	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-688-01)Marketed from Aug 18, 2018
68382-688-05	6838206880568382068805	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-688-05)Marketed from Aug 18, 2018
68382-688-10	6838206881068382068810	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-688-10)Marketed from Aug 18, 2018
68382-688-16	6838206881668382068816	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-688-16)Marketed from Aug 18, 2018
68382-688-77	6838206887768382068877	10 BLISTER PACK in 1 CARTON (68382-688-77) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 18, 2018
68382-688-95	6838206889568382068895	300 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-688-95)Marketed from Aug 18, 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 — 30 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 210184
Marketing start: Aug 18, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
Identifiers: Product ID 68382-688_18f1ad21-11a1-4d2d-b5bc-a88ac8c02f45SPL ID 18f1ad21-11a1-4d2d-b5bc-a88ac8c02f45SPL set ID 1c857df2-9cce-40de-95c3-b1274ed1e1bcRxCUI 198034, 198035, 198036UNII I9ZF7L6G2LUPC 0368382688774, 0368382690777
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

N468382068801 followed by a unit qualifier and the quantity

Package 68382-0688-01. 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 Jan 16, 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 68382-688

What is NDC 68382-688?: 68382-688 is the product NDC for Nifedipine, Nifedipine 30 mg/1 tablet, extended release, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. It has 6 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 210184

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

FDA NDC Directory listings under ANDA 210184
Product	Strength	Form · route	Labeler	Product NDC
Nifedipine	Nifedipine 60 mg/1	Tablet, Extended releaseOral	Zydus Pharmaceuticals (USA) Inc.	68382-689
Nifedipine	Nifedipine 90 mg/1	Tablet, Extended releaseOral	Zydus Pharmaceuticals (USA) Inc.	68382-690
Nifedipine	Nifedipine 30 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	70771-1365
Nifedipine	Nifedipine 60 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	70771-1366
Nifedipine	Nifedipine 90 mg/1	Tablet, Extended releaseOral	Zydus Lifesciences Limited	70771-1367