FDA.reportPublic FDA data

Ampicillin Sodium

Product NDC
25021-197
11-digit product format
250210197
Labeler code
25021
Product ID
25021-197_0e1963ba-9650-44ba-9ba0-1817b0e73512
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA201404
Marketing category
ANDA
Marketing start
2025-01-15
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 Sodium
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
25021-197-99Ampicillin Sodium1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11
25021-197-99Ampicillin Sodium100 mL in 1 BOTTLEINJECTION, POWDER, FOR SOLUTION1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-197-99EA - Each25021-1972cd4dd0b-3726-4330-ae58-1d360169d83e12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-197AMPICILLIN SODIUM INJECTION, POWDER, FOR SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 2 package rows20250115_5b3796dd-6f81-4999-ae2b-a13a72795729.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
789980ampicillin 100 MG/ML Injectable SolutionPSN5b3796dd-6f81-4999-ae2b-a13a727957291
789980ampicillin 100 MG/ML Injectable SolutionSCD5b3796dd-6f81-4999-ae2b-a13a727957291
789980ampicillin (as ampicillin sodium) 100 MG/ML Injectable SolutionSY5b3796dd-6f81-4999-ae2b-a13a727957291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-197-99250210197991 BOTTLE in 1 CARTON (25021-197-99) / 100 mL in 1 BOTTLE1 bottle2025-01-15NoNoHistorical