What is NDC 69097-997?

69097-997 is the product NDC for Diltiazem Hydrochloride, Diltiazem hydrochloride 420 mg/1 tablet, extended release, listed with the FDA by Cipla USA, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Cipla USA, Inc., NDC labeler code 69097. 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?

223 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 69097-997

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-997Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0997Add 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
69097-997-02	6909709970269097099702	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-997-02)Marketed from Jun 12, 2023
69097-997-05	6909709970569097099705	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (69097-997-05)Marketed from Jun 12, 2023

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): Diltiazem Hydrochloride
Generic name (nonproprietary): diltiazem hydrochloride
Active ingredients: Diltiazem hydrochloride — 420 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Cipla USA, Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216327
Marketing start: Jun 12, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers: Product ID 69097-997_8e10fac2-bb4b-4d93-ad8c-4fd93278a91eSPL ID 8e10fac2-bb4b-4d93-ad8c-4fd93278a91eSPL set ID bce61158-201d-458c-be0c-9bdd2d3a0becRxCUI 830874, 830877, 830879, 830882, 830897, 830900UNII 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

N469097099702 followed by a unit qualifier and the quantity

Package 69097-0997-02. 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 Aug 1, 2025.

Indications (excerpt from the label)

Diltiazem Hydrochloride Extended-Release Tablet is a nondihydropyridine calcium channel blocker indicated for: treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. It can be used alone or in combination with other antihypertensives. ( 1.1 ) improving exercise tolerance in patients with chronic stable angina. ( 1.2 ) 1.1 Hypertension Diltiazem Hydrochloride Extended-Release Tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69097-997

What is NDC 69097-997?: 69097-997 is the product NDC for Diltiazem Hydrochloride, Diltiazem hydrochloride 420 mg/1 tablet, extended release, listed with the FDA by Cipla USA, Inc.. 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?: Cipla USA, Inc., NDC labeler code 69097. 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?: 223 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 60 mg/1	Capsule, Extended releaseOral	Cranbury Pharmaceuticals, LLC	27808-322	27808-0322-01
Diltiazem Hydrochloride	Diltiazem hydrochloride 90 mg/1	Capsule, Extended releaseOral	Cranbury Pharmaceuticals, LLC	27808-323	27808-0323-01
Diltiazem Hydrochloride	Diltiazem hydrochloride 120 mg/1	Capsule, Extended releaseOral	Cranbury Pharmaceuticals, LLC	27808-324	27808-0324-01
Diltiazem hydrochloride	Diltiazem hydrochloride 30 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1929	70771-1929-0170771-1929-05
Diltiazem hydrochloride	Diltiazem hydrochloride 60 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1930	70771-1930-0170771-1930-05
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 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

All 224 Diltiazem Hydrochloride NDCs

Other NDCs under ANDA 216327

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

FDA NDC Directory listings under ANDA 216327
Product	Strength	Form · route	Labeler	Product NDC
Diltiazem Hydrochloride	Diltiazem hydrochloride 120 mg/1	Tablet, Extended releaseOral	ScieGen Pharmaceuticals, Inc.	50228-495
Diltiazem Hydrochloride	Diltiazem hydrochloride 180 mg/1	Tablet, Extended releaseOral	ScieGen Pharmaceuticals, Inc.	50228-496
Diltiazem Hydrochloride	Diltiazem hydrochloride 240 mg/1	Tablet, Extended releaseOral	ScieGen Pharmaceuticals, Inc.	50228-497
Diltiazem Hydrochloride	Diltiazem hydrochloride 300 mg/1	Tablet, Extended releaseOral	ScieGen Pharmaceuticals, Inc.	50228-498
Diltiazem Hydrochloride	Diltiazem hydrochloride 360 mg/1	Tablet, Extended releaseOral	ScieGen Pharmaceuticals, Inc.	50228-499
Diltiazem Hydrochloride	Diltiazem hydrochloride 420 mg/1	Tablet, Extended releaseOral	ScieGen Pharmaceuticals, Inc.	50228-500
Diltiazem Hydrochloride	Diltiazem hydrochloride 120 mg/1	Tablet, Extended releaseOral	Cipla USA, Inc.	69097-992
Diltiazem Hydrochloride	Diltiazem hydrochloride 180 mg/1	Tablet, Extended releaseOral	Cipla USA, Inc.	69097-993
Diltiazem Hydrochloride	Diltiazem hydrochloride 240 mg/1	Tablet, Extended releaseOral	Cipla USA, Inc.	69097-994
Diltiazem Hydrochloride	Diltiazem hydrochloride 300 mg/1	Tablet, Extended releaseOral	Cipla USA, Inc.	69097-995
Diltiazem Hydrochloride	Diltiazem hydrochloride 360 mg/1	Tablet, Extended releaseOral	Cipla USA, Inc.	69097-996