NDC 12634-789

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 ID12634-789_46625c1e-8ee1-4178-e054-00144ff88e88
NDC12634-789
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 Strength1000 mg/1
Pharm ClassesBiguanide [EPC],Biguanides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 12634-789-00

10 TABLET, FILM COATED in 1 BOTTLE (12634-789-00)
Marketing Start Date2011-01-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 12634-789-66 [12634078966]

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

NDC 12634-789-81 [12634078981]

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

NDC 12634-789-96 [12634078996]

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

NDC 12634-789-01 [12634078901]

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

NDC 12634-789-12 [12634078912]

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

NDC 12634-789-85 [12634078985]

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

NDC 12634-789-93 [12634078993]

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

NDC 12634-789-80 [12634078980]

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

NDC 12634-789-45 [12634078945]

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

NDC 12634-789-61 [12634078961]

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

NDC 12634-789-18 [12634078918]

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

NDC 12634-789-82 [12634078982]

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

NDC 12634-789-79 [12634078979]

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

NDC 12634-789-78 [12634078978]

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

NDC 12634-789-50 [12634078950]

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

NDC 12634-789-54 [12634078954]

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

NDC 12634-789-98 [12634078998]

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

NDC 12634-789-69 [12634078969]

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

NDC 12634-789-99 [12634078999]

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

NDC 12634-789-97 [12634078997]

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

NDC 12634-789-57 [12634078957]

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

NDC 12634-789-91 [12634078991]

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

NDC 12634-789-84 [12634078984]

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

NDC 12634-789-94 [12634078994]

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

NDC 12634-789-60 [12634078960]

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

NDC 12634-789-63 [12634078963]

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

NDC 12634-789-40 [12634078940]

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

NDC 12634-789-67 [12634078967]

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

NDC 12634-789-92 [12634078992]

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

NDC 12634-789-52 [12634078952]

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

NDC 12634-789-00 [12634078900]

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

NDC 12634-789-09 [12634078909]

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

NDC 12634-789-59 [12634078959]

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

NDC 12634-789-42 [12634078942]

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

NDC 12634-789-71 [12634078971]

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

NDC 12634-789-74 [12634078974]

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

NDC 12634-789-95 [12634078995]

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

NDC 12634-789-90 [12634078990]

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

Drug Details

Active Ingredients

IngredientStrength
METFORMIN HYDROCHLORIDE1000 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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