NDC 49502-476

Pretomanid

Pretomanid

Pretomanid is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Specialty L.p.. The primary component is Pretomanid.

Product ID49502-476_5dd0a13a-c8f0-413f-8306-92c479195e0f
NDC49502-476
Product TypeHuman Prescription Drug
Proprietary NamePretomanid
Generic NamePretomanid
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-11-07
Marketing CategoryNDA / NDA
Application NumberNDA212862
Labeler NameMylan Specialty L.P.
Substance NamePRETOMANID
Active Ingredient Strength200 mg/1
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 49502-476-26

26 TABLET in 1 BOTTLE (49502-476-26)
Marketing Start Date2019-11-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49502-476-28 [49502047628]

Pretomanid TABLET
Marketing CategoryNDA
Application NumberNDA212862
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-15
Marketing End Date2019-10-18

NDC 49502-476-32 [49502047632]

Pretomanid TABLET
Marketing CategoryNDA
Application NumberNDA212862
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-14
Marketing End Date2019-10-18

NDC 49502-476-93 [49502047693]

Pretomanid TABLET
Marketing CategoryNDA
Application NumberNDA212862
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-15
Marketing End Date2019-10-18

NDC 49502-476-26 [49502047626]

Pretomanid TABLET
Marketing CategoryNDA
Application NumberNDA212862
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-11-07

Drug Details

Active Ingredients

IngredientStrength
PRETOMANID200 mg/1

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