FDA.reportPublic FDA data

AMPICILLIN

Product NDC
72572-016
11-digit product format
725720016
Labeler code
72572
Product ID
72572-016_6d84c7a4-10e5-4762-ae14-ab2d3231a367
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA062719
Marketing category
ANDA
Marketing start
2020-12-01
Substance
AMPICILLIN SODIUM
Active strength
1 g/1
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 SODIUM1 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJFN36L5S8K
Rxcui1721475, 1721476

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
72572-016-01AMPICILLIN1 in 1 VIAL, GLASSINJECTION, POWDER, FOR SOLUTION16
72572-016-10AMPICILLIN10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-016-01EA - Each72572-016de91e573-3328-4220-94cf-43158df532fd12021-01-08
72572-016-10EA - Each72572-0165a13d044-5004-404f-9951-70a70196df2912021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-016AMPICILLIN INJECTION, POWDER, FOR SOLUTION [CIVICA, INC.]5Current NDC, Legacy NDC, 2 package rows20240712_a194f310-a669-4d8f-8c04-ee9ca01939b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721475ampicillin 1 GM InjectionPSNa194f310-a669-4d8f-8c04-ee9ca01939b16
1721476ampicillin 2 GM InjectionPSNa194f310-a669-4d8f-8c04-ee9ca01939b16
1721475ampicillin 1000 MG InjectionSCDa194f310-a669-4d8f-8c04-ee9ca01939b16
1721476ampicillin 2000 MG InjectionSCDa194f310-a669-4d8f-8c04-ee9ca01939b16
1721475ampicillin (as ampicillin sodium) 1 GM InjectionSYa194f310-a669-4d8f-8c04-ee9ca01939b16
1721476ampicillin (as ampicillin sodium) 2 GM InjectionSYa194f310-a669-4d8f-8c04-ee9ca01939b16
1721475ampicillin 1 GM InjectionSYa194f310-a669-4d8f-8c04-ee9ca01939b16
1721476ampicillin 2 GM InjectionSYa194f310-a669-4d8f-8c04-ee9ca01939b16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72572-016-01725720016011 in 1 VIAL, GLASSHistorical
72572-016-107257200161010 VIAL, GLASS in 1 CARTON (72572-016-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (72572-016-01) 2020-12-010000-00-00NoNoCurrent