Indapamide

Product NDC
16571-876
11-digit product format
165710876
Labeler code
16571
Product ID
16571-876_7c1bd14b-7f8f-4ad6-9c3c-e6a0d9aad1cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Indapamide
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA074461
Marketing category
ANDA
Marketing start
2023-06-22
Substance
INDAPAMIDE
Active strength
2.5 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide-like Diuretic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Indapamide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INDAPAMIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF089I0511L
Rxcui197815, 197816

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2bda0d04-c82b-7786-6ed9-2a416b849e7aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-876-01Indapamide100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-876-01EA - Each16571-8766ba7e7b7-9294-47fc-b8ee-98ad4062d2ee12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-876INDAPAMIDE TABLET [RISING PHARMA HOLDINGS, INC.]2Current NDC, 1 package rows20230627_0687ed93-4761-4f9c-887d-95309c03f60e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197815indapamide 1.25 MG Oral TabletPSN0687ed93-4761-4f9c-887d-95309c03f60e2
197816indapamide 2.5 MG Oral TabletPSN0687ed93-4761-4f9c-887d-95309c03f60e2
197815indapamide 1.25 MG Oral TabletSCD0687ed93-4761-4f9c-887d-95309c03f60e2
197816indapamide 2.5 MG Oral TabletSCD0687ed93-4761-4f9c-887d-95309c03f60e2
197816indapamide (as indapamide hemihydrate) 2.5 MG Oral TabletSY0687ed93-4761-4f9c-887d-95309c03f60e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16571-876-0116571087601100 TABLET in 1 BOTTLE (16571-876-01) 100 tablet2023-06-22NoNoHistorical