FDA.reportPublic FDA data

ampicillin

Product NDC
25021-137
11-digit product format
250210137
Labeler code
25021
Product ID
25021-137_c3bd533d-1831-4030-8fc0-97c93f4803b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ampicillin
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA090354
Marketing category
ANDA
Marketing start
2014-07-01
Substance
AMPICILLIN SODIUM
Active strength
2 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 SODIUM2 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
25021-137-20ampicillin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1017
25021-137-20ampicillin1 in 1 VIALINJECTION, POWDER, FOR SOLUTION117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-137-20EA - Each25021-1375dc40f5b-e8db-48ff-a972-23a6e861b3cf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ampicillin sodiumACTIVE INGREDIENTJFN36L5S8KAMPICILLIN INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]7
ampicillinACTIVE MOIETY7C782967RDAMPICILLIN INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-137AMPICILLIN INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]17Current NDC, Legacy NDC, 2 package rows20240328_9d2aebe8-4f04-49dd-b1e5-80b962868dc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721475ampicillin 1 GM InjectionPSN9d2aebe8-4f04-49dd-b1e5-80b962868dc317
1721476ampicillin 2 GM InjectionPSN9d2aebe8-4f04-49dd-b1e5-80b962868dc317
1721475ampicillin 1000 MG InjectionSCD9d2aebe8-4f04-49dd-b1e5-80b962868dc317
1721476ampicillin 2000 MG InjectionSCD9d2aebe8-4f04-49dd-b1e5-80b962868dc317
1721475ampicillin (as ampicillin sodium) 1 GM InjectionSY9d2aebe8-4f04-49dd-b1e5-80b962868dc317
1721476ampicillin (as ampicillin sodium) 2 GM InjectionSY9d2aebe8-4f04-49dd-b1e5-80b962868dc317
1721475ampicillin 1 GM InjectionSY9d2aebe8-4f04-49dd-b1e5-80b962868dc317
1721476ampicillin 2 GM InjectionSY9d2aebe8-4f04-49dd-b1e5-80b962868dc317

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-137-202502101372010 VIAL in 1 CARTON (25021-137-20) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL10 vial2014-07-010000-00-00NoNoCurrent