NDC 68210-0106

DEXTROMETHORPHAN Hydrobromide

Dextromethorphan Hydrobromide

DEXTROMETHORPHAN Hydrobromide is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Spirit Pharmaceuticals Llc. The primary component is Dextromethorphan Hydrobromide.

Product ID68210-0106_6999b5db-104c-cf46-e053-2a91aa0a4ef6
NDC68210-0106
Product TypeHuman Otc Drug
Proprietary NameDEXTROMETHORPHAN Hydrobromide
Generic NameDextromethorphan Hydrobromide
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2018-04-10
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameSpirit Pharmaceuticals LLC
Substance NameDEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength15 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68210-0106-1

1 BOTTLE in 1 CARTON (68210-0106-1) > 15 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Start Date2018-04-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68210-0106-1 [68210010601]

DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-04-10

NDC 68210-0106-2 [68210010602]

DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-03-12

NDC 68210-0106-3 [68210010603]

DEXTROMETHORPHAN HYDROBROMIDE CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-03-12

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1

OpenFDA Data

SPL SET ID:ac4d581b-4f09-40a0-a75f-d23d9c6fc0b9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1090487

    • NDC Crossover Matching brand name "DEXTROMETHORPHAN Hydrobromide" or generic name "Dextromethorphan Hydrobromide"

    NDCBrand NameGeneric Name
    68210-0005DEXTROMETHORPHAN HydrobromideDEXTROMETHORPHAN Hydrobromide
    68210-1530DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE
    68210-0106DEXTROMETHORPHAN HydrobromideDEXTROMETHORPHAN Hydrobromide
    59105-006DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE
    55629-011DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE
    0363-0300Adult Wal TussinDextromethorphan Hydrobromide
    41520-903careone tussinDextromethorphan Hydrobromide
    0031-8694Childrens Robitussin Cough Long-Actingdextromethorphan hydrobromide
    36800-415Cough ReliefDEXTROMETHORPHAN HYDROBROMIDE
    12090-0015CreomulsionDEXTROMETHORPHAN HYDROBROMIDE
    12090-0024CreomulsionDEXTROMETHORPHAN HYDROBROMIDE
    41250-473daytime coughdextromethorphan hydrobromide
    41163-300Equaline tussin coughDextromethorphan Hydrobromide
    24385-493Good Neighbor Pharmacy TussinDextromethorphan Hydrobromide
    41250-066Mixed Berry Sore Throat and Cough lozengeDextromethorphan Hydrobromide
    0031-9302Robitussin Direct Coughdextromethorphan hydrobromide
    0031-8743ROBITUSSIN LONG-ACTING COUGHGELSdextromethorphan hydrobromide
    0372-0043Scot-Tussin Diabetes Cough Formula with DMdextromethorphan hydrobromide
    15187-043Scot-Tussin Diabetes Cough Formula with DMdextromethorphan hydrobromide
    15187-045Scot-Tussin Diabetes Cough Formula with DMdextromethorphan hydrobromide
    49873-301Stonadextromethorphan hydrobromide
    36800-300Topcare TussinDextromethorphan Hydrobromide
    37808-504Tussin CoughDextromethorphan Hydrobromide
    42507-300Tussin CoughDextromethorphan Hydrobromide
    11822-0493Tussin Long Acting CoughDextromethorphan Hydrobromide
    37000-447VicksDextromethorphan Hydrobromide
    37000-449VicksDextromethorphan Hydrobromide
    37000-565Vicks DayQuilDextromethorphan Hydrobromide
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.