FDA.reportPublic FDA data

Ampicillin

Product NDC
0781-2144
11-digit product format
007812144
Labeler code
0781
Product ID
0781-2144_e8f470a8-ec75-4c1e-84d8-766372f61cf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA064082
Marketing category
ANDA
Marketing start
1995-08-29
Marketing end
0000-00-00
Substance
AMPICILLIN TRIHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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
0781-2144-012025-07-30C16284748780-19d75b9d0-fdcc-f424-e053-dadaa90a57ceAmpicillin Capsules, USP
0781-2144-052025-07-30C16284748780-19d75b9d0-fdcc-f424-e053-dadaa90a57ceAmpicillin Capsules, USP
0781-2144-012020-07-20C16284748780-19d75b9d0-fdcc-f424-e053-dadaa90a57ceAmpicillin Capsules, USP
0781-2144-052020-07-20C16284748780-19d75b9d0-fdcc-f424-e053-dadaa90a57ceAmpicillin Capsules, USP
0781-2144-012020-01-31C16284748780-19d75b9d0-fdcc-f424-e053-dadaa90a57ceAmpicillin Capsules, USP
0781-2144-052020-01-31C16284748780-19d75b9d0-fdcc-f424-e053-dadaa90a57ceAmpicillin Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-2144-01Ampicillin100 in 1 BOTTLECAPSULE10018
0781-2144-05Ampicillin500 in 1 BOTTLECAPSULE50018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-2144-01EA - Each0781-2144b746cebb-1126-4b6f-9c50-927c7c9dd43112012-07-24
0781-2144-05EA - Each0781-21448968b407-9184-42ff-9e2b-8d2d460f7a9c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMPICILLIN TRIHYDRATEACTIVE INGREDIENTHXQ6A1N7R6AMPICILLIN CAPSULE [SANDOZ INC]12
AMPICILLINACTIVE MOIETY7C782967RDAMPICILLIN CAPSULE [SANDOZ INC]12
AMMONIAINACTIVE INGREDIENT5138Q19F1XAMPICILLIN CAPSULE [SANDOZ INC]12
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMPICILLIN CAPSULE [SANDOZ INC]12
GELATININACTIVE INGREDIENT2G86QN327LAMPICILLIN CAPSULE [SANDOZ INC]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMPICILLIN CAPSULE [SANDOZ INC]12
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TAMPICILLIN CAPSULE [SANDOZ INC]12
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMPICILLIN CAPSULE [SANDOZ INC]12
SHELLACINACTIVE INGREDIENT46N107B71OAMPICILLIN CAPSULE [SANDOZ INC]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMPICILLIN CAPSULE [SANDOZ INC]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-2144AMPICILLIN CAPSULE [SANDOZ INC]17Legacy NDC, 2 package rows20240514_0a66c5c3-63bf-46e3-835e-26b555ab6954.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313800ampicillin 250 MG Oral CapsulePSN0a66c5c3-63bf-46e3-835e-26b555ab695418
308212ampicillin 500 MG Oral CapsulePSN0a66c5c3-63bf-46e3-835e-26b555ab695418
313800ampicillin 250 MG Oral CapsuleSCD0a66c5c3-63bf-46e3-835e-26b555ab695418
308212ampicillin 500 MG Oral CapsuleSCD0a66c5c3-63bf-46e3-835e-26b555ab695418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-2144-0100781214401100 CAPSULE in 1 BOTTLE (0781-2144-01) 100 capsule1995-08-290000-00-00NoNoCurrent
0781-2144-0500781214405500 CAPSULE in 1 BOTTLE (0781-2144-05) 500 capsule1995-08-290000-00-00NoNoCurrent