FDA.reportPublic FDA data

rifampin

Product NDC
50090-5709
11-digit product format
500905709
Labeler code
50090
Product ID
50090-5709_37783510-9524-4bee-89d1-c96e36d6791a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rifampin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090034
Marketing category
ANDA
Marketing start
2014-01-08
Substance
RIFAMPIN
Active strength
300 mg/1
Pharmacologic classes
Rifamycin Antibacterial [EPC], Rifamycins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIFAMPIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVJT6J7R4TR
Rxcui198202

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
29eec95f-f163-42e8-88a8-3cb43899b2b7Product name320160405
26abd97e-907b-0cb8-84ee-99fb15297adaProduct name120140508
7cf7f62d-3767-728f-c117-96e96c1ed8bfProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5709-02023-02-07C16284748780-1f386c64a-01e9-0266-e053-dadaa90a7c1aRifampin Capsules USP
50090-5709-32023-02-07C16284748780-1f386c64a-01e9-0266-e053-dadaa90a7c1aRifampin Capsules USP
50090-5709-02023-01-30C16284748780-1f386c64a-01e9-0266-e053-dadaa90a7c1aRifampin Capsules USP
50090-5709-32023-01-30C16284748780-1f386c64a-01e9-0266-e053-dadaa90a7c1aRifampin Capsules USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5709-0rifampin30 in 1 BOTTLECAPSULE307
50090-5709-3rifampin60 in 1 BOTTLECAPSULE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5709-0EA - Each50090-5709ee886d36-a4e7-4c73-a735-6136c9c7c05a12026-02-05
50090-5709-3EA - Each50090-5709a270b03b-6af0-486a-a734-294b953f5fdf12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5709RIFAMPIN CAPSULE [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20230911_d53b6998-6e3b-4c6f-8465-2af6897d1efe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198202rifAMPin 300 MG Oral CapsulePSNd53b6998-6e3b-4c6f-8465-2af6897d1efe7
198202rifampin 300 MG Oral CapsuleSCDd53b6998-6e3b-4c6f-8465-2af6897d1efe7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5709-05009057090030 CAPSULE in 1 BOTTLE (50090-5709-0) 30 capsule2021-09-240000-00-00NoNoCurrent
50090-5709-35009057090360 CAPSULE in 1 BOTTLE (50090-5709-3) 60 capsule2021-09-240000-00-00NoNoCurrent