12634-789 NDC - METFORMIN HYDROCHLORIDE ()

Drug Information

  • Product NDC: 12634-789
  • Proprietary Name: Metformin Hydrochloride
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Apotheca Inc.
Product Type:
FDA Application Number: ANDA091184
Marketing Category: ANDA
Start Marketing Date:1/31/2011

Package Information

No. Package Code Package Description Billing Unit
112634-789-0010 TABLET, FILM COATED in 1 BOTTLE (12634-789-00)
212634-789-01100 TABLET, FILM COATED in 1 BOTTLE (12634-789-01)
312634-789-0935 TABLET, FILM COATED in 1 BOTTLE (12634-789-09)
412634-789-12120 TABLET, FILM COATED in 1 BOTTLE (12634-789-12)
512634-789-18180 TABLET, FILM COATED in 1 BOTTLE (12634-789-18)
612634-789-4040 TABLET, FILM COATED in 1 BOTTLE (12634-789-40)
712634-789-4242 TABLET, FILM COATED in 1 BOTTLE (12634-789-42)
812634-789-4545 TABLET, FILM COATED in 1 BOTTLE (12634-789-45)
912634-789-5050 TABLET, FILM COATED in 1 BOTTLE (12634-789-50)
1012634-789-5212 TABLET, FILM COATED in 1 BLISTER PACK (12634-789-52)
1112634-789-5414 TABLET, FILM COATED in 1 BLISTER PACK (12634-789-54)
1212634-789-5720 TABLET, FILM COATED in 1 BLISTER PACK (12634-789-57)
1312634-789-5930 TABLET, FILM COATED in 1 BLISTER PACK (12634-789-59)
1412634-789-6060 TABLET, FILM COATED in 1 BOTTLE (12634-789-60)
1512634-789-6110 TABLET, FILM COATED in 1 BLISTER PACK (12634-789-61)
1612634-789-633 TABLET, FILM COATED in 1 BLISTER PACK (12634-789-63)
1712634-789-666 TABLET, FILM COATED in 1 BLISTER PACK (12634-789-66)
1812634-789-677 TABLET, FILM COATED in 1 BLISTER PACK (12634-789-67)
1912634-789-699 TABLET, FILM COATED in 1 BLISTER PACK (12634-789-69)
2012634-789-7130 TABLET, FILM COATED in 1 BOTTLE (12634-789-71)
2112634-789-7424 TABLET, FILM COATED in 1 BOTTLE (12634-789-74)
2212634-789-7828 TABLET, FILM COATED in 1 BOTTLE (12634-789-78)
2312634-789-7925 TABLET, FILM COATED in 1 BOTTLE (12634-789-79)
2412634-789-8020 TABLET, FILM COATED in 1 BOTTLE (12634-789-80)
2512634-789-8121 TABLET, FILM COATED in 1 BOTTLE (12634-789-81)
2612634-789-8212 TABLET, FILM COATED in 1 BOTTLE (12634-789-82)
2712634-789-8414 TABLET, FILM COATED in 1 BOTTLE (12634-789-84)
2812634-789-8515 TABLET, FILM COATED in 1 BOTTLE (12634-789-85)
2912634-789-9090 TABLET, FILM COATED in 1 BOTTLE (12634-789-90)
3012634-789-911 TABLET, FILM COATED in 1 BLISTER PACK (12634-789-91)
3112634-789-922 TABLET, FILM COATED in 1 BOTTLE (12634-789-92)
3212634-789-933 TABLET, FILM COATED in 1 BOTTLE (12634-789-93)
3312634-789-944 TABLET, FILM COATED in 1 BOTTLE (12634-789-94)
3412634-789-955 TABLET, FILM COATED in 1 BOTTLE (12634-789-95)
3512634-789-966 TABLET, FILM COATED in 1 BOTTLE (12634-789-96)
3612634-789-977 TABLET, FILM COATED in 1 BOTTLE (12634-789-97)
3712634-789-988 TABLET, FILM COATED in 1 BOTTLE (12634-789-98)
3812634-789-999 TABLET, FILM COATED in 1 BOTTLE (12634-789-99)

NDC Record

Field Name Field Value Definition
PRODUCT NDC12634-789The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEMetformin HydrochlorideThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE1/31/2011This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA091184This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEApotheca Inc.Name of Company corresponding to the labeler code segment of the Product NDC.

Download Record

Download this NDC record record in Text format: Export

Download this NDC record record in Excel (CSV) format: Export

Download this NDC record record in XML format: Export

This page was last updated on: 4/4/2025

Previous Code
Next Code