NDC codes

FDA NDC Directory
Product NDC (as listed)0378-6090Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00378-6090Add 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
0378-6090-010037860900100378609001100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6090-01)Marketed from May 2, 1997

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 — 90 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Labeler
Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074910
Marketing start
Listing expires
Other FDA classes
Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers
Product ID 0378-6090_17bfacaf-75db-4179-9a06-244e94a28554SPL ID 17bfacaf-75db-4179-9a06-244e94a28554SPL set ID ec7e93b8-666c-4d2f-8d08-07931e09f748RxCUI 830865, 830869, 830872UNII OLH94387TEUPC 0303786120017, 0303786060016, 0303786090013
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

N400378609001 followed by a unit qualifier and the quantity

Package 00378-6090-01. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Diltiazem hydrochloride extended-release capsules (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-6090

What is NDC 0378-6090?
0378-6090 is the product NDC for Diltiazem Hydrochloride, Diltiazem hydrochloride 90 mg/1 capsule, extended release, listed with the FDA by Mylan Pharmaceuticals Inc.. 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?
Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 074910

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

FDA NDC Directory listings under ANDA 074910
ProductStrengthForm · routeLabelerProduct NDC
Diltiazem HydrochlorideDiltiazem hydrochloride 60 mg/1Capsule, Extended releaseOralMylan Pharmaceuticals Inc.0378-6060
Diltiazem HydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralMylan Pharmaceuticals Inc.0378-6120
Diltiazem HydrochlorideDiltiazem hydrochloride 60 mg/1Capsule, Extended releaseOralSafecor Health LLC48433-030
Diltiazem HydrochlorideDiltiazem hydrochloride 90 mg/1Capsule, Extended releaseOralSafecor Health LLC48433-031
Diltiazem HydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralSafecor Health LLC48433-032
Diltiazem HydrochlorideDiltiazem hydrochloride 60 mg/1Capsule, Extended releaseOralMylan Institutional Inc.51079-924
Diltiazem HydrochlorideDiltiazem hydrochloride 90 mg/1Capsule, Extended releaseOralMylan Institutional Inc.51079-925
Diltiazem HydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralMylan Institutional Inc.51079-926
Diltiazem HydrochlorideDiltiazem hydrochloride 120 mg/1Capsule, Extended releaseOralCoupler LLC67046-1481

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