NDC 0597-0041

Micardis

Telmisartan

Micardis is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Telmisartan.

• Product ID: 0597-0041_31be27bf-4f71-d52f-05f4-d837c83a3f10
• NDC: 0597-0041
• Product Type: Human Prescription Drug
• Proprietary Name: Micardis
• Generic Name: Telmisartan
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2000-12-01
• Marketing Category: NDA / NDA
• Application Number: NDA020850
• Labeler Name: Boehringer Ingelheim Pharmaceuticals, Inc.
• Substance Name: TELMISARTAN
• Active Ingredient Strength: 80 mg/1
• Pharm Classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0597-0041-37

3 BLISTER PACK in 1 CARTON (0597-0041-37) > 10 TABLET in 1 BLISTER PACK

• Marketing Start Date: 2000-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0597-0041-70 [00597004170]

Micardis TABLET

• Marketing Category: NDA
• Application Number: NDA020850
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2000-12-01
• Marketing End Date: 2017-12-31

NDC 0597-0041-37 [00597004137]

Micardis TABLET

• Marketing Category: NDA
• Application Number: NDA020850
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2000-12-01

Drug Details

Active Ingredients

Ingredient	Strength
TELMISARTAN	80 mg/1

OpenFDA Data

• SPL SET ID: cfb9309f-e0df-4a55-9542-0e869fce05fb
• Manufacturer:
  • Boehringer Ingelheim Pharmaceuticals, Inc.
• UNII:
  • U5SYW473RQ
• RxNorm Concept Unique ID - RxCUI:
  • 282755
  • 284531
  • 213431
  • 205305
  • 213432
  • 205304

Pharmacological Class

• Angiotensin 2 Receptor Antagonists [MoA]
• Angiotensin 2 Receptor Blocker [EPC]

NDC Crossover Matching brand name "Micardis" or generic name "Telmisartan"

NDC	Brand Name	Generic Name
0597-0039	Micardis	telmisartan
0597-0040	Micardis	telmisartan
0597-0041	Micardis	telmisartan
0054-0542	Telmisartan	telmisartan
0054-0543	Telmisartan	telmisartan
0054-0544	Telmisartan	telmisartan
0378-2920	Telmisartan	telmisartan
0378-2921	Telmisartan	telmisartan
0378-2922	Telmisartan	telmisartan
0591-3293	Telmisartan	Telmisartan
0591-3294	Telmisartan	Telmisartan
0781-5372	Telmisartan	Telmisartan
0781-5374	Telmisartan	Telmisartan
0781-5378	Telmisartan	Telmisartan
13668-156	TELMISARTAN	TELMISARTAN
13668-157	TELMISARTAN	TELMISARTAN
13668-158	TELMISARTAN	TELMISARTAN
31722-802	Telmisartan	Telmisartan
31722-803	Telmisartan	Telmisartan
31722-804	Telmisartan	Telmisartan
42291-790	Telmisartan	Telmisartan