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NDC 49483-0621-10 METFORMIN HCL 850 mg/1 Details
METFORMIN HCL 850 mg/1
METFORMIN HCL is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by TIME CAP LABORATORIES, INC. The primary component is METFORMIN HYDROCHLORIDE.
MedlinePlus Drug Summary
Metformin is used alone or with other medications, including insulin, to treat type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood). Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in your blood. It decreases the amount of glucose you absorb from your food and the amount of glucose made by your liver. Metformin also increases your body's response to insulin, a natural substance that controls the amount of glucose in the blood. Metformin is not used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood). Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Taking medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.
Related Packages: 49483-0621-10Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Metformin
Product Information
NDC | 49483-0621 |
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Product ID | 49483-621_9af12167-4e7a-8e00-e053-2a95a90a270d |
Associated GPIs | 27250050000340 |
GCN Sequence Number | 016441 |
GCN Sequence Number Description | metformin HCl TABLET 850 MG ORAL |
HIC3 | C4L |
HIC3 Description | ANTIHYPERGLYCEMIC, BIGUANIDE TYPE |
GCN | 10811 |
HICL Sequence Number | 004763 |
HICL Sequence Number Description | METFORMIN HCL |
Brand/Generic | Generic |
Proprietary Name | METFORMIN HCL |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | METFORMIN HCL |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | TABLET, FILM COATED |
Route | ORAL |
Active Ingredient Strength | 850 |
Active Ingredient Units | mg/1 |
Substance Name | METFORMIN HYDROCHLORIDE |
Labeler Name | TIME CAP LABORATORIES, INC |
Pharmaceutical Class | Biguanide [EPC], Biguanides [CS] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA090888 |
Listing Certified Through | 2024-12-31 |
Package
Package Images



NDC 49483-0621-10 (49483062110)
NDC Package Code | 49483-621-10 |
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Billing NDC | 49483062110 |
Package | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-621-10) |
Marketing Start Date | 2017-06-05 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 0.02471 |
Pricing Unit | EA |
Effective Date | 2024-02-21 |
NDC Description | METFORMIN HCL 850 MG TABLET |
Pharmacy Type Indicator | C/I |
OTC | N |
Explanation Code | 1 |
Classification for Rate Setting | G |
As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 542cec22-eeae-4704-9bb6-4176640e5ea8 Details
HOW SUPPLIED
HOW SUPPLIED
HOW SUPPLIED
INGREDIENTS AND APPEARANCE
METFORMIN HCL
metformin hcl tablet, film coated |
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METFORMIN HCL
metformin hcl tablet, film coated |
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METFORMIN HCL
metformin hcl tablet, film coated |
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Labeler - TIME CAP LABORATORIES, INC (037052099) |
Registrant - TIME CAP LABORATORIES, INC (037052099) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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MARKSANS PHARMA LIMITED | 925822975 | manufacture(49483-620, 49483-621, 49483-622) |