NDC 0378-0080

Indapamide

Indapamide

Indapamide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Indapamide.

• Product ID: 0378-0080_a92c5cdc-8cb6-44ad-ae7d-d6f415f1e8c6
• NDC: 0378-0080
• Product Type: Human Prescription Drug
• Proprietary Name: Indapamide
• Generic Name: Indapamide
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 1996-03-28
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074461
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: INDAPAMIDE
• Active Ingredient Strength: 3 mg/1
• Pharm Classes: Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0378-0080-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0080-01)

• Marketing Start Date: 1996-03-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-0080-77 [00378008077]

Indapamide TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA074461
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-02-16

NDC 0378-0080-01 [00378008001]

Indapamide TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA074461
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1996-03-28

NDC 0378-0080-10 [00378008010]

Indapamide TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA074461
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1996-03-28

Drug Details

Active Ingredients

Ingredient	Strength
INDAPAMIDE	2.5 mg/1

OpenFDA Data

• SPL SET ID: 5c098a1b-cca0-4c27-8e0e-3a27cb2fc003
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • F089I0511L
• RxNorm Concept Unique ID - RxCUI:
  • 197816
  • 197815

Pharmacological Class

• Increased Diuresis [PE]
• Thiazide-like Diuretic [EPC]
• Increased Diuresis [PE]
• Thiazide-like Diuretic [EPC]

NDC Crossover Matching brand name "Indapamide" or generic name "Indapamide"

NDC	Brand Name	Generic Name
0228-2571	Indapamide	Indapamide
0228-2597	Indapamide	Indapamide
0378-0069	Indapamide	Indapamide
0378-0080	Indapamide	Indapamide
21695-576	Indapamide	Indapamide
42291-348	Indapamide	Indapamide
42291-349	Indapamide	Indapamide
43975-217	INDAPAMIDE	INDAPAMIDE
43975-304	INDAPAMIDE	INDAPAMIDE
50090-0510	Indapamide	Indapamide
51079-868	Indapamide	Indapamide
51407-024	Indapamide	Indapamide
51407-025	Indapamide	Indapamide
55700-281	Indapamide	Indapamide
55700-641	Indapamide	Indapamide
62559-510	Indapamide	Indapamide
62559-511	Indapamide	Indapamide
63629-1953	Indapamide	Indapamide
63629-1954	Indapamide	Indapamide
68151-1294	Indapamide	Indapamide
68788-7247	Indapamide	Indapamide
70518-1324	Indapamide	Indapamide
63629-7892	Indapamide	Indapamide
71335-1541	Indapamide	Indapamide