What is NDC 71335-0643?

71335-0643 is the product NDC for Diltiazem Hydrochloride, Diltiazem hydrochloride 180 mg/1 capsule, extended release, listed with the FDA by Bryant Ranch Prepack. It has 2 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Diltiazem Hydrochloride?

220 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Diltiazem Hydrochloride NDC 71335-0643

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-0643Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-0643Add 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	Copy
71335-0643-1	71335064301	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0643-1)Marketed from Jan 5, 2018
71335-0643-2	71335064302	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0643-2)Marketed from Jan 5, 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): Diltiazem Hydrochloride
Generic name (nonproprietary): diltiazem hydrochloride
Active ingredients: Diltiazem hydrochloride — 180 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075116
Marketing start: Dec 28, 1999
Listing expires: Dec 31, 2026
Other FDA classes: Calcium Channel Antagonists (Mechanism)
Identifiers: Product ID 71335-0643_7e6a9719-c345-4c8c-96ed-5f21905e536aSPL ID 7e6a9719-c345-4c8c-96ed-5f21905e536aSPL set ID 609e97e5-ebc7-4268-84ea-f279284c89e2RxCUI 830845UNII OLH94387TE
Pharmacologic class: 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

N471335064301 followed by a unit qualifier and the quantity

Package 71335-0643-01. 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 19, 2020.

Indications (excerpt from the label)

INDICATIONS AND USAGE Diltiazem Hydrochloride Extended-Release Capsules (Once-a-Day Dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem Hydrochloride Extended-Release Capsules (Once-a-Day Dosage) are indicated for the management of chronic stable angina and angina due to coronary artery spasm.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-0643

What is NDC 71335-0643?: 71335-0643 is the product NDC for Diltiazem Hydrochloride, Diltiazem hydrochloride 180 mg/1 capsule, extended release, listed with the FDA by Bryant Ranch Prepack. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Diltiazem Hydrochloride.
What is the active ingredient?: Diltiazem hydrochloride.
Who is the labeler?: Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Diltiazem Hydrochloride?: 220 other product NDCs are listed under this name. See all Diltiazem Hydrochloride 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 Diltiazem Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Diltiazem hydrochloride	Diltiazem hydrochloride 30 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-199	72578-0199-0172578-0199-05
Diltiazem hydrochloride	Diltiazem hydrochloride 60 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-200	72578-0200-0172578-0200-05
Diltiazem hydrochloride	Diltiazem hydrochloride 90 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-201	72578-0201-0172578-0201-05
Diltiazem hydrochloride	Diltiazem hydrochloride 120 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-202	72578-0202-0172578-0202-05
Diltiazem hydrochloride	Diltiazem hydrochloride 60 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1930	70771-1930-0170771-1930-05
Diltiazem hydrochloride	Diltiazem hydrochloride 30 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1929	70771-1929-0170771-1929-05
Diltiazem hydrochloride	Diltiazem hydrochloride 90 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1931	70771-1931-0170771-1931-05
Diltiazem hydrochloride	Diltiazem hydrochloride 120 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1932	70771-1932-0170771-1932-05
Diltiazem Hydrochloride	Diltiazem hydrochloride 60 mg/1	Capsule, Extended releaseOral	Safecor Health LLC	48433-030	48433-0030-20
Diltiazem Hydrochloride	Diltiazem hydrochloride 90 mg/1	Capsule, Extended releaseOral	Safecor Health LLC	48433-031	48433-0031-20

All 221 Diltiazem Hydrochloride NDCs

Other NDCs under ANDA 075116

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

FDA NDC Directory listings under ANDA 075116
Product	Strength	Form · route	Labeler	Product NDC
Diltiazem Hydrochloride	Diltiazem hydrochloride 180 mg/1	Capsule, Extended releaseOral	Bryant Ranch Prepack	71335-0634
Diltiazem Hydrochloride	Diltiazem hydrochloride 240 mg/1	Capsule, Extended releaseOral	NuCare Pharmaceuticals,Inc.	68071-4005
Diltiazem Hydrochloride	Diltiazem hydrochloride 240 mg/1	Capsule, Extended releaseOral	OCEANSIDE PHARMACEUTICALS	68682-997
Diltiazem Hydrochloride	Diltiazem hydrochloride 120 mg/1	Capsule, Extended releaseOral	OCEANSIDE PHARMACEUTICALS	68682-993
Diltiazem Hydrochloride	Diltiazem hydrochloride 180 mg/1	Capsule, Extended releaseOral	OCEANSIDE PHARMACEUTICALS	68682-994
Diltiazem Hydrochloride	Diltiazem hydrochloride 300 mg/1	Capsule, Extended releaseOral	OCEANSIDE PHARMACEUTICALS	68682-998
Diltiazem Hydrochloride	Diltiazem HCl 240 mg/1	Capsule, Extended releaseOral	A-S Medication Solutions	50090-7815
Diltiazem Hydrochloride	Diltiazem hydrochloride 240 mg/1	Capsule, Extended releaseOral	Bryant Ranch Prepack	71335-0867
Diltiazem Hydrochloride	Diltiazem hydrochloride 120 mg/1	Capsule, Extended releaseOral	Bryant Ranch Prepack	71335-1389
Diltiazem Hydrochloride	Diltiazem hydrochloride 120 mg/1	Capsule, Extended releaseOral	NuCare Pharmaceuticals,Inc.	68071-4664