NDC codes

FDA NDC Directory
Product NDC (as listed)63304-721Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63304-0721Add 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 NDC11-digit (billing)PackageCopy
63304-721-0563304072105500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-721-05)Marketed from Oct 31, 2018
63304-721-306330407213030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-721-30)Marketed from Oct 31, 2018
63304-721-906330407219090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-721-90)Marketed from Oct 31, 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)
Diltiazem hydrochloride
Generic name (nonproprietary)
diltiazem hydrochloride
Active ingredients
Diltiazem hydrochloride — 300 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 63304
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203023
Marketing start
Listing expires
Other FDA classes
Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers
Product ID 63304-721_35b4a94c-9d26-e406-e063-6394a90aa9fcSPL ID 35b4a94c-9d26-e406-e063-6394a90aa9fcSPL set ID 976d9dd0-4f11-4439-b84e-0c0f0e018d8bRxCUI 830795, 830801, 830837, 830845, 830861UNII 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

N463304072105 followed by a unit qualifier and the quantity

Package 63304-0721-05. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Diltiazem hydrochloride extended-release capsules, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP 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 63304-721

What is NDC 63304-721?
63304-721 is the product NDC for Diltiazem hydrochloride, Diltiazem hydrochloride 300 mg/1 capsule, extended release, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 3 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?
Sun Pharmaceutical Industries, Inc., NDC labeler code 63304. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Diltiazem hydrochlorideDiltiazem hydrochloride 30 mg/1TabletOralZydus Lifesciences Limited70771-192970771-1929-0170771-1929-05
Diltiazem hydrochlorideDiltiazem hydrochloride 60 mg/1TabletOralZydus Lifesciences Limited70771-193070771-1930-0170771-1930-05
Diltiazem hydrochlorideDiltiazem hydrochloride 90 mg/1TabletOralZydus Lifesciences Limited70771-193170771-1931-0170771-1931-05
Diltiazem hydrochlorideDiltiazem hydrochloride 120 mg/1TabletOralZydus Lifesciences Limited70771-193270771-1932-0170771-1932-05
Diltiazem hydrochlorideDiltiazem hydrochloride 90 mg/1TabletOralViona Pharmaceuticals Inc72578-20172578-0201-0172578-0201-05
Diltiazem hydrochlorideDiltiazem hydrochloride 30 mg/1TabletOralViona Pharmaceuticals Inc72578-19972578-0199-0172578-0199-05
Diltiazem hydrochlorideDiltiazem hydrochloride 60 mg/1TabletOralViona Pharmaceuticals Inc72578-20072578-0200-0172578-0200-05
Diltiazem hydrochlorideDiltiazem hydrochloride 120 mg/1TabletOralViona Pharmaceuticals Inc72578-20272578-0202-0172578-0202-05
Diltiazem HydrochlorideDiltiazem hydrochloride 90 mg/1Capsule, Extended releaseOralSafecor Health LLC48433-03148433-0031-20
Diltiazem HydrochlorideDiltiazem hydrochloride 60 mg/1Capsule, Extended releaseOralSafecor Health LLC48433-03048433-0030-20

All 221 Diltiazem hydrochloride NDCs

Other NDCs under ANDA 203023

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

FDA NDC Directory listings under ANDA 203023
ProductStrengthForm · routeLabelerProduct NDC
Diltiazem hydrochlorideDiltiazem hydrochloride 240 mg/1Capsule, Extended releaseOralSun Pharmaceutical Industries, Inc.63304-720
Diltiazem hydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralSun Pharmaceutical Industries, Inc.63304-718
Diltiazem hydrochlorideDiltiazem hydrochloride 180 mg/1Capsule, Extended releaseOralSun Pharmaceutical Industries, Inc.63304-719
Diltiazem hydrochlorideDiltiazem hydrochloride 360 mg/1Capsule, Extended releaseOralSun Pharmaceutical Industries, Inc.63304-722
Diltiazem hydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-6328

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Diltiazem hydrochloride NDC 63304-721 | National Drug Code | Med-Code