Ampicillin

Product NDC
52959-389
11-digit product format
529590389
Labeler code
52959
Product ID
52959-389_8cd46ed0-6629-479f-9c35-22fbeb811d71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA062882
Marketing category
ANDA
Marketing start
1988-02-25
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-389-20Ampicillin20 in 1 BOTTLE, PLASTICCAPSULE201
52959-389-28Ampicillin28 in 1 BOTTLE, PLASTICCAPSULE281
52959-389-30Ampicillin30 in 1 BOTTLE, PLASTICCAPSULE301
52959-389-40Ampicillin40 in 1 BOTTLE, PLASTICCAPSULE401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-389-20EA - Each52959-389c7e99b41-aedf-497d-8012-386617cd719612013-02-13
52959-389-28EA - Each52959-389a7178d43-207f-445e-b860-34b1e950706e12013-02-13
52959-389-30EA - Each52959-389ecb6b451-8655-4ced-9a07-97d4d78acc3a12013-02-13
52959-389-40EA - Each52959-389b49817ce-e7d8-4d27-b8a9-4f01583bad1b12013-02-13

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-389AMPICILLIN CAPSULE [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 4 package rows20120829_e6040d92-0b8f-4808-a375-eece4aeeff18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308212ampicillin 500 MG Oral CapsulePSNe6040d92-0b8f-4808-a375-eece4aeeff181
308212ampicillin 500 MG Oral CapsuleSCDe6040d92-0b8f-4808-a375-eece4aeeff181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-389-205295903892020 in 1 BOTTLE, PLASTICHistorical
52959-389-285295903892828 in 1 BOTTLE, PLASTICHistorical
52959-389-305295903893030 in 1 BOTTLE, PLASTICHistorical
52959-389-405295903894040 in 1 BOTTLE, PLASTICHistorical