FDA.reportPublic FDA data

Ampicillin

Product NDC
70518-2607
11-digit product format
705182607
Labeler code
70518
Product ID
70518-2607_4faa3c23-9796-a19e-e063-6294a90acf7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA064082
Marketing category
ANDA
Marketing start
2020-02-28
Substance
AMPICILLIN TRIHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ampicillin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPICILLIN TRIHYDRATE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiHXQ6A1N7R6
Rxcui308212

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
70518-2607-02022-01-30C16284748780-1d6a99b39-7d14-a426-e053-dadaa90af4c2Ampicillin Capsules, USP
70518-2607-02022-01-30C16284748780-1d6a99b39-7d14-a426-e053-dadaa90af4c2Ampicillin Capsules, USP
70518-2607-02022-01-28C16284748780-1d6a99b39-7d14-a426-e053-dadaa90af4c2Ampicillin Capsules, USP
70518-2607-02022-01-28C16284748780-1d6a99b39-7d14-a426-e053-dadaa90af4c2Ampicillin Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2607-0Ampicillin28 in 1 BOTTLE, PLASTICCAPSULE2813
70518-2607-1Ampicillin28 in 1 BOTTLE, PLASTICCAPSULE2813

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2607-0EA - Each70518-2607c7cb81ab-5f2f-4a70-9a9b-10376da3893c12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2607AMPICILLIN CAPSULE [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 2 package rows20250322_4134cd79-c895-4e6e-b1d5-8e01c38bf2d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308212ampicillin 500 MG Oral CapsulePSN4134cd79-c895-4e6e-b1d5-8e01c38bf2d113
308212ampicillin 500 MG Oral CapsuleSCD4134cd79-c895-4e6e-b1d5-8e01c38bf2d113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2607-07051826070028 CAPSULE in 1 BOTTLE, PLASTIC (70518-2607-0) 28 capsule2020-02-280000-00-00NoNoCurrent
70518-2607-17051826070128 CAPSULE in 1 BOTTLE, PLASTIC (70518-2607-1) 28 capsule2025-07-17NoNoHistorical