NDC 49999-116

metformin hydrochloride

Metformin Hydrochloride

metformin hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Quality Care Products, Llc. The primary component is Metformin Hydrochloride.

Product ID49999-116_f6ec559e-8f51-4b0a-8729-58e1308c59ff
NDC49999-116
Product TypeHuman Prescription Drug
Proprietary Namemetformin hydrochloride
Generic NameMetformin Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-03-22
Marketing CategoryANDA / ANDA
Application NumberANDA090564
Labeler NameQuality Care Products, LLC
Substance NameMETFORMIN HYDROCHLORIDE
Active Ingredient Strength1000 mg/1
Pharm ClassesBiguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 49999-116-90

90 TABLET in 1 BOTTLE (49999-116-90)
Marketing Start Date2019-03-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49999-116-30 [49999011630]

metformin hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090564
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-04-22
Marketing End Date2011-12-01

NDC 49999-116-60 [49999011660]

metformin hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090564
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-04-22
Marketing End Date2018-03-29

NDC 49999-116-90 [49999011690]

metformin hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA090564
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-22
Marketing End Date2019-10-30

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE1000 mg/1

OpenFDA Data

SPL SET ID:62d676ef-7fd1-49ff-863d-b0e9eb03bee2
Manufacturer
UNII

Pharmacological Class

  • Biguanide [EPC]
  • Biguanides [CS]

NDC Crossover Matching brand name "metformin hydrochloride" or generic name "Metformin Hydrochloride"

NDCBrand NameGeneric Name
0093-1048Metformin HydrochlorideMetformin Hydrochloride
0093-1049Metformin HydrochlorideMetformin Hydrochloride
0093-7212Metformin HydrochlorideMetformin Hydrochloride
0093-7214Metformin HydrochlorideMetformin Hydrochloride
0093-7267Metformin HydrochlorideMetformin Hydrochloride
0179-1979Metformin HydrochlorideMetformin Hydrochloride
0185-4416metformin hydrochloridemetformin hydrochloride
0378-6001Metformin Hydrochloridemetformin
0378-6002Metformin Hydrochloridemetformin
0378-7185Metformin Hydrochloridemetformin hydrochloride
0378-7186Metformin Hydrochloridemetformin hydrochloride
0378-7187Metformin Hydrochloridemetformin hydrochloride
0440-5739Metformin HydrochlorideMetformin Hydrochloride
0440-5745Metformin HydrochlorideMetformin Hydrochloride
0440-5746Metformin HydrochlorideMetformin Hydrochloride
0591-2411Metformin HydrochlorideMetformin Hydrochloride
0591-2412Metformin HydrochlorideMetformin Hydrochloride
0591-2719Metformin HydrochlorideMetformin Hydrochloride
0591-2720Metformin HydrochlorideMetformin Hydrochloride
0615-5583Metformin HydrochlorideMetformin Hydrochloride
0615-7626Metformin HydrochlorideMetformin Hydrochloride
0615-7627Metformin HydrochlorideMetformin Hydrochloride
0615-7628Metformin HydrochlorideMetformin Hydrochloride
0615-7661Metformin HydrochlorideMetformin Hydrochloride
0615-7662Metformin HydrochlorideMetformin Hydrochloride
0615-7663Metformin HydrochlorideMetformin Hydrochloride
0615-7847METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE
0615-7982Metformin HydrochlorideMetformin Hydrochloride
67877-217Metformin HydrochlorideMetformin Hydrochloride
67877-221Metformin HydrochlorideMetformin Hydrochloride
67877-218Metformin HydrochlorideMetformin Hydrochloride
67877-159METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE
67877-414Metformin HydrochlorideMetformin Hydrochloride
67877-413Metformin HydrochlorideMetformin Hydrochloride
68071-1781Metformin hydrochlorideMetformin hydrochloride
68071-1419Metformin hydrochlorideMetformin hydrochloride
68071-1815Metformin hydrochlorideMetformin hydrochloride
68071-3117Metformin hydrochlorideMetformin hydrochloride
68071-3200Metformin hydrochlorideMetformin hydrochloride
68071-1774Metformin hydrochlorideMetformin hydrochloride
68071-3226Metformin HydrochlorideMetformin Hydrochloride
68071-1927METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE
68071-3370METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE
68071-3126Metformin hydrochlorideMetformin hydrochloride
68071-3212Metformin HydrochlorideMetformin Hydrochloride
68071-4153Metformin HydrochlorideMetformin Hydrochloride
68071-4525Metformin hydrochlorideMetformin hydrochloride
68071-4560Metformin hydrochlorideMetformin hydrochloride
68071-4605Metformin hydrochlorideMetformin hydrochloride
68071-4270Metformin HydrochlorideMetformin Hydrochloride

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.