Bisoprolol Fumarate and Hydrochlorothiazide

Product NDC
50090-6413
11-digit product format
500906413
Labeler code
50090
Product ID
50090-6413_b4dbad3e-db70-448f-8946-c9a2ae7bec87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bisoprolol Fumarate and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA215562
Marketing category
ANDA
Marketing start
2021-11-04
Substance
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Active strength
5; 6.25 mg/1; mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bisoprolol Fumarate and Hydrochlorothiazide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISOPROLOL FUMARATE5 mg/1
HYDROCHLOROTHIAZIDE6.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUR59KN573L, 0J48LPH2TH
Rxcui854919

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
97e4a60d-917d-ef62-dc8a-bd557b62b708Product name720260129
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6413-0Bisoprolol Fumarate and Hydrochlorothiazide30 in 1 BOTTLETABLET303
50090-6413-2Bisoprolol Fumarate and Hydrochlorothiazide90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6413-0EA - Each50090-64138cebf0cf-3218-45ea-bff6-b72510bac93412023-05-05
50090-6413-2EA - Each50090-641322eb168c-f393-4c1f-bcc6-8af2aa372a3e12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6413BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20230414_90bb2207-2eaf-495b-a222-c69d4db9e7a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
854919bisoprolol fumarate 5 MG / hydroCHLOROthiazide 6.25 MG Oral TabletPSN90bb2207-2eaf-495b-a222-c69d4db9e7a33
854919bisoprolol fumarate 5 MG / hydrochlorothiazide 6.25 MG Oral TabletSCD90bb2207-2eaf-495b-a222-c69d4db9e7a33
854919bisoprolol fumarate 5 MG / HCTZ 6.25 MG Oral TabletSY90bb2207-2eaf-495b-a222-c69d4db9e7a33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6413-05009064130030 TABLET in 1 BOTTLE (50090-6413-0) 30 tablet2023-03-28NoNoHistorical
50090-6413-25009064130290 TABLET in 1 BOTTLE (50090-6413-2) 90 tablet2023-03-28NoNoHistorical