Prescription drug · ANDA

Diltiazem Hydrochloride NDC 0904-7218

Diltiazem hydrochloride 180 mg/1 · Capsule, Extended release · Oral · Major Pharmaceuticals

NDC codes

FDA NDC Directory
Product NDC (as listed)0904-7218Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-7218Add 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
0904-7218-610090472186100904721861100 BLISTER PACK in 1 CARTON (0904-7218-61) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 9, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 180 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Labeler
Major PharmaceuticalsNDC labeler code 0904
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205231
Marketing start
Listing expires
Other FDA classes
Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers
Product ID 0904-7218_16c20dcf-681e-48d9-8a60-5de830bb1007SPL ID 16c20dcf-681e-48d9-8a60-5de830bb1007SPL set ID e7476adc-a940-4e76-a1dd-c418de493bc0RxCUI 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

N400904721861 followed by a unit qualifier and the quantity

Package 00904-7218-61. 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 (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, USP (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 0904-7218

What is NDC 0904-7218?
0904-7218 is the product NDC for Diltiazem Hydrochloride, Diltiazem hydrochloride 180 mg/1 capsule, extended release, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, 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?
Major Pharmaceuticals, NDC labeler code 0904. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Diltiazem HydrochlorideDiltiazem hydrochloride 60 mg/1Capsule, Extended releaseOralCranbury Pharmaceuticals, LLC27808-32227808-0322-01
Diltiazem HydrochlorideDiltiazem hydrochloride 90 mg/1Capsule, Extended releaseOralCranbury Pharmaceuticals, LLC27808-32327808-0323-01
Diltiazem HydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralCranbury Pharmaceuticals, LLC27808-32427808-0324-01
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 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 90 mg/1TabletOralViona Pharmaceuticals Inc72578-20172578-0201-0172578-0201-05

All 224 Diltiazem Hydrochloride NDCs

Other NDCs under ANDA 205231

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

FDA NDC Directory listings under ANDA 205231
ProductStrengthForm · routeLabelerProduct NDC
Diltiazem HydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralMajor Pharmaceuticals0904-7217
Diltiazem HydrochlorideDiltiazem hydrochloride 240 mg/1Capsule, Extended releaseOralMajor Pharmaceuticals0904-7219
Diltiazem HydrochlorideDiltiazem hydrochloride 300 mg/1Capsule, Extended releaseOralMajor Pharmaceuticals0904-7220
Diltiazem HydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC24979-026
Diltiazem HydrochlorideDiltiazem hydrochloride 180 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC24979-027
Diltiazem HydrochlorideDiltiazem hydrochloride 240 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC24979-028
Diltiazem HydrochlorideDiltiazem hydrochloride 300 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC24979-029
Diltiazem HydrochlorideDiltiazem hydrochloride 360 mg/1Capsule, Extended releaseOralUpsher-Smith Laboratories, LLC24979-030
Diltiazem HydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-5416
Diltiazem HydrochlorideDiltiazem hydrochloride 240 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-5452
Diltiazem HydrochlorideDiltiazem hydrochloride 180 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-5466
Diltiazem HydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralGolden State Medical Supply, Inc.51407-473
Diltiazem HydrochlorideDiltiazem hydrochloride 180 mg/1Capsule, Extended releaseOralGolden State Medical Supply, Inc.51407-474
Diltiazem HydrochlorideDiltiazem hydrochloride 240 mg/1Capsule, Extended releaseOralGolden State Medical Supply, Inc.51407-475
Diltiazem HydrochlorideDiltiazem hydrochloride 300 mg/1Capsule, Extended releaseOralGolden State Medical Supply, Inc.51407-476
Diltiazem HydrochlorideDiltiazem hydrochloride 240 mg/1Capsule, Extended releaseOralCardinal Health 107, LLC55154-2627
Diltiazem HydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralCardinal Health 107, LLC55154-4317
Diltiazem HydrochlorideDiltiazem hydrochloride 180 mg/1Capsule, Extended releaseOralCardinal Health 107, LLC55154-4321
Diltiazem HydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-2129
Diltiazem HydrochlorideDiltiazem hydrochloride 180 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-2739

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