FDA.reportPublic FDA data

Ampicillin

Product NDC
70860-118
11-digit product format
708600118
Labeler code
70860
Product ID
70860-118_2cc9237d-bad7-3781-e063-6394a90a81c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ampicillin sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Athenex Pharmaceutical Division, LLC.
Application
ANDA201404
Marketing category
ANDA
Marketing start
2018-05-31
Marketing end
2026-09-30
Substance
AMPICILLIN SODIUM
Active strength
10 g/100mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ampicillin

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70860-118-992024-03-01C16284748780-11030e365-57d6-111a-e063-dadaa90a10e2Ampicillin for Injection, USP
70860-118-992024-01-30C16284748780-11030e365-57d6-111a-e063-dadaa90a10e2Ampicillin for Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70860-118-99Ampicillin1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION14
70860-118-99Ampicillin100 mL in 1 BOTTLEINJECTION, POWDER, FOR SOLUTION1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-118-99EA - Each70860-1189cfc49cc-d037-4349-8dba-0e93b0d5d98012018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70860-118AMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.]4Current NDC, Legacy NDC, 2 package rows20250130_06b1c203-600c-4083-986a-d1d471b56e43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
789980ampicillin 100 MG/ML Injectable SolutionPSN06b1c203-600c-4083-986a-d1d471b56e434
789980ampicillin 100 MG/ML Injectable SolutionSCD06b1c203-600c-4083-986a-d1d471b56e434
789980ampicillin (as ampicillin sodium) 100 MG/ML Injectable SolutionSY06b1c203-600c-4083-986a-d1d471b56e434

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70860-118-99708600118991 BOTTLE in 1 CARTON (70860-118-99) / 100 mL in 1 BOTTLE1 bottle2018-05-312026-09-30NoNoCurrent