FDA.reportPublic FDA data

Labetalol Hydrochloride

Product NDC
0409-2339
11-digit product format
004092339
Labeler code
0409
Product ID
0409-2339_7ba44762-b760-4a8f-adce-65bf78cc5d98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Labetalol Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA075239
Marketing category
ANDA
Marketing start
2005-10-18
Substance
LABETALOL HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-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
Labetalol Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LABETALOL HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1GEV3BAW9J
Rxcui1234256

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
baf61d8c-dcd3-e95d-db84-9bb0d0a2b77fProduct name220220311
759f1c41-9262-4238-8cee-33988631aaf4Product name520220217
3b2edbb4-6acf-4674-b1d9-22addd3dad21Product name120210527
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-2339-24Labetalol Hydrochloride4 mL in 1 CARTRIDGEINJECTION, SOLUTION420
0409-2339-34Labetalol Hydrochloride10 in 1 PACKAGEINJECTION, SOLUTION1020
0409-2339-34Labetalol Hydrochloride1 in 1 CARTONINJECTION, SOLUTION120

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-2339-24ML - Milliliter0409-2339a5c8008c-66a8-48e4-9b63-293132b32a2512019-07-02
0409-2339-34ML - Milliliter0409-2339f791cad4-bc8b-42f8-b853-5eb984e9fef412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LABETALOL HYDROCHLORIDEACTIVE INGREDIENT1GEV3BAW9JLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
LABETALOLACTIVE MOIETYR5H8897N95LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]13
LABETALOL HYDROCHLORIDEACTIVE INGREDIENT1GEV3BAW9JLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
LABETALOLACTIVE MOIETYR5H8897N95LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILABETALOL HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-2339LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]20Current NDC, Legacy NDC, 3 package rows20210531_d3579d45-a964-40fe-e3a2-a3a997c8b7b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1234256labetalol HCl 20 MG in 4 ML CartridgePSNd3579d45-a964-40fe-e3a2-a3a997c8b7b920
12342564 ML labetalol hydrochloride 5 MG/ML CartridgeSCDd3579d45-a964-40fe-e3a2-a3a997c8b7b920
1234256labetalol HCl 20 MG per 4 ML CartridgeSYd3579d45-a964-40fe-e3a2-a3a997c8b7b920
1234256labetalol HCl 20 MG in 4 ML CartridgePSN1b96ddc9-d0c3-488a-a113-66491fd3d89912
12342564 ML labetalol hydrochloride 5 MG/ML CartridgeSCD1b96ddc9-d0c3-488a-a113-66491fd3d89912
1234256labetalol HCl 20 MG per 4 ML CartridgeSY1b96ddc9-d0c3-488a-a113-66491fd3d89912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-2339-24004092339244 mL in 1 CARTRIDGE4 mlHistorical
0409-2339-340040923393410 CARTON in 1 PACKAGE (0409-2339-34) / 1 CARTRIDGE in 1 CARTON / 4 mL in 1 CARTRIDGE (0409-2339-24) 10 carton2005-10-180000-00-00NoNoCurrent