FDA.reportPublic FDA data

Ampicillin

Product NDC
10544-122
11-digit product format
105440122
Labeler code
10544
Product ID
10544-122_116d482a-f6e9-6130-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA062882
Marketing category
ANDA
Marketing start
2010-03-30
Marketing end
0000-00-00
Substance
AMPICILLIN TRIHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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
10544-122-282020-01-31C16284748780-19d75b9cf-f071-f424-e053-dadaa90a57ceAMPICILLIN CAPSULES, USP 250 mg and 500 mg AMPICILLIN FOR ORAL SUSPENSION, USP 125 mg/5 mL and 250 mg/5 mL Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-122-28Ampicillin28 in 1 BOTTLECAPSULE281

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-122-28EA - Each10544-1224bf2aeba-070d-4f36-93d4-339e72a41f7112015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMPICILLIN TRIHYDRATEACTIVE INGREDIENTHXQ6A1N7R6AMPICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
AMPICILLINACTIVE MOIETY7C782967RDAMPICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMPICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMPICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMPICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LAMPICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMPICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMPICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMPICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMPICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-122AMPICILLIN CAPSULE [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 1 package rows20150317_116d482a-f6e8-6130-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308212ampicillin 500 MG Oral CapsulePSN116d482a-f6e8-6130-e054-00144ff88e881
308212ampicillin 500 MG Oral CapsuleSCD116d482a-f6e8-6130-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-122-281054401222828 in 1 BOTTLEHistorical