NDC 12634-757

Metformin Hydrochloride

Metformin Hydrochloride

Metformin Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Apotheca Inc.. The primary component is Metformin Hydrochloride.

Product ID12634-757_46625c1e-8ee1-4178-e054-00144ff88e88
NDC12634-757
Product TypeHuman Prescription Drug
Proprietary NameMetformin Hydrochloride
Generic NameMetformin Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-01-31
Marketing CategoryANDA / ANDA
Application NumberANDA091184
Labeler NameApotheca Inc.
Substance NameMETFORMIN HYDROCHLORIDE
Active Ingredient Strength850 mg/1
Pharm ClassesBiguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 12634-757-00

10 TABLET, FILM COATED in 1 BOTTLE (12634-757-00)
Marketing Start Date2011-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-757-00 [12634075700]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-98 [12634075798]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-59 [12634075759]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-97 [12634075797]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-09 [12634075709]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-93 [12634075793]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-18 [12634075718]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-80 [12634075780]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-12 [12634075712]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-71 [12634075771]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-45 [12634075745]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-01 [12634075701]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-96 [12634075796]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-67 [12634075767]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-91 [12634075791]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-50 [12634075750]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-92 [12634075792]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-52 [12634075752]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-79 [12634075779]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-82 [12634075782]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-63 [12634075763]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-57 [12634075757]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-99 [12634075799]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-42 [12634075742]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-69 [12634075769]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-94 [12634075794]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-40 [12634075740]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-66 [12634075766]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-85 [12634075785]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-90 [12634075790]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-54 [12634075754]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-61 [12634075761]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-84 [12634075784]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-74 [12634075774]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-95 [12634075795]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-60 [12634075760]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-81 [12634075781]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

NDC 12634-757-78 [12634075778]

Metformin Hydrochloride TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA091184
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-31

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE850 mg/1

OpenFDA Data

SPL SET ID:4661d307-78b2-2f5b-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861007
  • 861010
  • 861004

    • 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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