NDC 0378-5280

Diltiazem Hydrochloride

Diltiazem Hydrochloride

Diltiazem Hydrochloride is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Diltiazem Hydrochloride.

• Product ID: 0378-5280_5b423e90-e707-4e0b-9461-f982cce226cf
• NDC: 0378-5280
• Product Type: Human Prescription Drug
• Proprietary Name: Diltiazem Hydrochloride
• Generic Name: Diltiazem Hydrochloride
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 1998-03-24
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075124
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: DILTIAZEM HYDROCHLORIDE
• Active Ingredient Strength: 180 mg/1
• Pharm Classes: Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0378-5280-05

500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-5280-05)

• Marketing Start Date: 1998-03-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-5280-77 [00378528077]

Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA075124
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1998-03-24
• Marketing End Date: 2017-11-28

NDC 0378-5280-01 [00378528001]

Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA075124
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-03-24
• Marketing End Date: 2019-10-31

NDC 0378-5280-05 [00378528005]

Diltiazem Hydrochloride CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA075124
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-03-24
• Marketing End Date: 2019-10-31

Drug Details

Active Ingredients

Ingredient	Strength
DILTIAZEM HYDROCHLORIDE	180 mg/1

OpenFDA Data

• SPL SET ID: dc932468-b50b-474e-b11a-66fbf2fac206
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • OLH94387TE
• RxNorm Concept Unique ID - RxCUI:
  • 830861
  • 830845
  • 830837
• UPC Code:
  • 0303785220770
  • 0303785280774
  • 0303785340775

Pharmacological Class

• Calcium Channel Antagonists [MoA]
• Calcium Channel Blocker [EPC]

NDC Crossover Matching brand name "Diltiazem Hydrochloride" or generic name "Diltiazem Hydrochloride"

NDC	Brand Name	Generic Name
0093-0318	Diltiazem Hydrochloride	Diltiazem Hydrochloride
0093-0319	Diltiazem Hydrochloride	Diltiazem Hydrochloride
0093-0320	Diltiazem Hydrochloride	Diltiazem Hydrochloride
0093-0321	Diltiazem Hydrochloride	Diltiazem Hydrochloride
0409-4350	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68071-1914	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68071-1928	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68071-1925	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68071-3290	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68071-4005	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68071-4155	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68071-4371	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68071-4242	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68071-4591	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68071-4664	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68151-2113	diltiazem hydrochloride	diltiazem hydrochloride
68151-2111	diltiazem hydrochloride	diltiazem hydrochloride
68151-2114	diltiazem hydrochloride	diltiazem hydrochloride
68151-1480	diltiazem hydrochloride	diltiazem hydrochloride
68151-2886	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68151-2112	diltiazem hydrochloride	diltiazem hydrochloride
68258-6024	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68258-6046	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68382-595	diltiazem hydrochloride	diltiazem hydrochloride
68382-596	diltiazem hydrochloride	diltiazem hydrochloride
68382-598	diltiazem hydrochloride	diltiazem hydrochloride
68382-599	diltiazem hydrochloride	diltiazem hydrochloride
68382-597	diltiazem hydrochloride	diltiazem hydrochloride
68682-705	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68682-006	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68682-997	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68682-007	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68682-708	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68682-994	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68682-009	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68682-706	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68682-707	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68682-998	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68682-709	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68682-008	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68682-993	Diltiazem Hydrochloride	Diltiazem Hydrochloride
68788-6893	Diltiazem Hydrochloride	Diltiazem Hydrochloride
70518-0040	Diltiazem Hydrochloride	Diltiazem Hydrochloride
70518-0109	Diltiazem Hydrochloride	Diltiazem Hydrochloride
70518-0820	Diltiazem Hydrochloride	Diltiazem Hydrochloride
70518-0783	Diltiazem Hydrochloride	Diltiazem Hydrochloride
70518-1096	Diltiazem Hydrochloride	Diltiazem Hydrochloride
70771-1034	diltiazem hydrochloride	diltiazem hydrochloride
70771-1033	diltiazem hydrochloride	diltiazem hydrochloride
70771-1032	diltiazem hydrochloride	diltiazem hydrochloride