FDA.reportPublic FDA data

Hydralazine Hydrochloride

Product NDC
82804-081
11-digit product format
828040081
Labeler code
82804
Product ID
82804-081_004f0059-4ede-4748-9489-45e27c177424
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydralazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040858
Marketing category
ANDA
Marketing start
2023-08-02
Substance
HYDRALAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDRALAZINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFD171B778Y
Rxcui905225

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3137695-e199-b3b3-2950-87a8ac429689Product name520260316
e9ed2ee5-d109-4795-bffe-c3b047717749Product name220250107
0284f4a6-db58-dacf-18fe-da73f4aeea88Product name420180827
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-081-30Hydralazine Hydrochloride30 in 1 BOTTLETABLET302
82804-081-60Hydralazine Hydrochloride60 in 1 BOTTLETABLET602
82804-081-72Hydralazine Hydrochloride120 in 1 BOTTLETABLET1202
82804-081-90Hydralazine Hydrochloride90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-081-30EA - Each82804-081b0f3b798-ee92-4e27-8987-2c1858bb5a1b12024-06-10
82804-081-60EA - Each82804-0811ddbb390-9747-4837-ac07-d044d80e2a6c12026-02-05
82804-081-72EA - Each82804-081e8323f2c-db7b-4aca-ad3e-66a45869789012026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-081HYDRALAZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1Current NDC, 4 package rows20240310_024ac6b8-5ce0-4435-9b11-b1806c511d7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905225hydrALAZINE HCl 25 MG Oral TabletPSN024ac6b8-5ce0-4435-9b11-b1806c511d7b2
905225hydralazine hydrochloride 25 MG Oral TabletSCD024ac6b8-5ce0-4435-9b11-b1806c511d7b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-081-308280400813030 TABLET in 1 BOTTLE (82804-081-30) 30 tablet2024-03-07NoNoHistorical
82804-081-608280400816060 TABLET in 1 BOTTLE (82804-081-60) 60 tablet2024-03-07NoNoHistorical
82804-081-7282804008172120 TABLET in 1 BOTTLE (82804-081-72) 120 tablet2025-07-18NoNoHistorical
82804-081-908280400819090 TABLET in 1 BOTTLE (82804-081-90) 90 tablet2024-03-07NoNoHistorical