FDA.reportPublic FDA data

Alfuzosin hydrochloride

Product NDC
29300-155
11-digit product format
293000155
Labeler code
29300
Product ID
29300-155_8190595a-be8e-4fd0-bcdf-30b6ba64ef5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alfuzosin hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA203192
Marketing category
ANDA
Marketing start
2016-03-15
Substance
ALFUZOSIN HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Adrenergic alpha-Antagonists [MoA], alpha-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALFUZOSIN HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii75046A1XTN
Rxcui861132

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8b671e1a-6f8a-5de4-69a7-83132df7952dProduct name320201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29300-155-01Alfuzosin hydrochloride100 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE10012
29300-155-13Alfuzosin hydrochloride30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE3012
29300-155-19Alfuzosin hydrochloride90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-155-01EA - Each29300-1552952c796-e969-47ff-b26e-8a936348127612016-11-08
29300-155-19EA - Each29300-1559c520b5a-a79b-4def-8850-5541c2fecab012016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-155ALFUZOSIN HYDROCHLORIDE TABLET, EXTENDED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.]12Current NDC, Legacy NDC, 3 package rows20220406_644295a9-75cb-4326-a71f-b0f4e0c4cf75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSNc01d4d6b-e030-4b8f-aaa9-4df0f3f8fbda103
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCDc01d4d6b-e030-4b8f-aaa9-4df0f3f8fbda103
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSYc01d4d6b-e030-4b8f-aaa9-4df0f3f8fbda103
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN644295a9-75cb-4326-a71f-b0f4e0c4cf7512
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD644295a9-75cb-4326-a71f-b0f4e0c4cf7512
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY644295a9-75cb-4326-a71f-b0f4e0c4cf7512
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSN0b3cf6f8-e19b-4462-9ba3-b948d5f7c7ab3
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCD0b3cf6f8-e19b-4462-9ba3-b948d5f7c7ab3
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSY0b3cf6f8-e19b-4462-9ba3-b948d5f7c7ab3
861132alfuzosin HCl 10 MG 24HR Extended Release Oral TabletPSNffbd22eb-9df5-e0ad-e053-6294a90a7d4e2
86113224 HR alfuzosin hydrochloride 10 MG Extended Release Oral TabletSCDffbd22eb-9df5-e0ad-e053-6294a90a7d4e2
861132alfuzosin hydrochloride 10 MG 24 HR Extended Release Oral TabletSYffbd22eb-9df5-e0ad-e053-6294a90a7d4e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29300-155-0129300015501100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-155-01) 2016-03-150000-00-00NoNoCurrent
29300-155-132930001551330 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-155-13) 2016-03-150000-00-00NoNoCurrent
29300-155-192930001551990 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29300-155-19) 2016-03-150000-00-00NoNoCurrent