NDC 63629-8166

Metformin Hydrochloride

Metformin Hydrochloride

Metformin Hydrochloride is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Metformin Hydrochloride.

Product ID63629-8166_63e312d7-ff74-40e7-8a15-72f17ede8c0a
NDC63629-8166
Product TypeHuman Prescription Drug
Proprietary NameMetformin Hydrochloride
Generic NameMetformin Hydrochloride
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2008-04-17
Marketing CategoryANDA / ANDA
Application NumberANDA078321
Labeler NameBryant Ranch Prepack
Substance NameMETFORMIN HYDROCHLORIDE
Active Ingredient Strength500 mg/1
Pharm ClassesBiguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63629-8166-1

180 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8166-1)
Marketing Start Date2019-07-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-8166-2 [63629816602]

Metformin Hydrochloride TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078321
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-29

NDC 63629-8166-1 [63629816601]

Metformin Hydrochloride TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA078321
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-29

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE500 mg/1

OpenFDA Data

SPL SET ID:cbdc435b-9a9e-4fad-a11a-d2aa81076ad2
Manufacturer
UNII

Pharmacological Class

  • Biguanide [EPC]
  • Biguanides [CS]
  • 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

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