FDA.reportPublic FDA data

Ampicillin

Product NDC
44567-104
11-digit product format
445670104
Labeler code
44567
Product ID
44567-104_3b6b0a4c-cb4e-40d3-9bec-97d204cdbe3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
WG Critical Care, LLC
Application
ANDA063142
Marketing category
ANDA
Marketing start
2012-05-10
Substance
AMPICILLIN SODIUM
Active strength
10 g/100mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPICILLIN SODIUM10 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJFN36L5S8K
Rxcui789980

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9d6ee0-43ae-43c7-aa52-3d5a936186d6Product name120250722
4fe9b92f-7dcd-4058-8def-e75f4dcd5ab3Product name220160201
c9385d77-2af7-47a4-bc97-1127e71caf9bProduct name320160201
05b6b9ae-4ba4-27ee-4c8c-f72b41de3815Product name520151207
b353113e-7b3d-4b1f-a286-b96a3a5eac85Product name320151026
8c59be9b-72b0-49e8-b7ef-1a80c10599deProduct name320150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44567-104-01Ampicillin100 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION10016
44567-104-01Ampicillin1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION116
44567-104-10Ampicillin100 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION10016
44567-104-10Ampicillin10 in 1 TRAYINJECTION, POWDER, FOR SOLUTION1016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44567-104-01EA - Each44567-104d2eb86d7-a24a-4ad4-b0b2-cb75f008762612020-02-13
44567-104-10EA - Each44567-1048cb2077f-707b-4218-a2f1-6abab528cd3612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMPICILLIN SODIUMACTIVE INGREDIENTJFN36L5S8KAMPICILLIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]7
AMPICILLINACTIVE MOIETY7C782967RDAMPICILLIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44567-104AMPICILLIN INJECTION, POWDER, FOR SOLUTION [WG CRITICAL CARE, LLC]15Current NDC, Legacy NDC, 4 package rows20240322_12b6ac82-ca74-4f88-99ea-ae4a1c419b70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
789980ampicillin 100 MG/ML Injectable SolutionPSN12b6ac82-ca74-4f88-99ea-ae4a1c419b7016
789980ampicillin 100 MG/ML Injectable SolutionSCD12b6ac82-ca74-4f88-99ea-ae4a1c419b7016
789980ampicillin (as ampicillin sodium) 100 MG/ML Injectable SolutionSY12b6ac82-ca74-4f88-99ea-ae4a1c419b7016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44567-104-01445670104011 VIAL in 1 CARTON (44567-104-01) / 100 mL in 1 VIAL1 vial2019-07-030000-00-00NoNoCurrent
44567-104-104456701041010 VIAL in 1 TRAY (44567-104-10) / 100 mL in 1 VIAL10 vial2012-05-100000-00-00NoNoCurrent