12634-910 NDC - PHENDIMETRAZINE TARTRATE ()

Drug Information

  • Product NDC: 12634-910
  • Proprietary Name: Phendimetrazine Tartrate
  • 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: NDA018074
Marketing Category: NDA
Start Marketing Date:9/6/1977

Package Information

No. Package Code Package Description Billing Unit
112634-910-0010 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-00)
212634-910-01100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-01)
312634-910-0935 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-09)
412634-910-4040 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-40)
512634-910-4242 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-42)
612634-910-4545 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-45)
712634-910-5050 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-50)
812634-910-5212 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (12634-910-52)
912634-910-5414 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (12634-910-54)
1012634-910-5720 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (12634-910-57)
1112634-910-5828 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (12634-910-58)
1212634-910-5930 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (12634-910-59)
1312634-910-6060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-60)
1412634-910-6110 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (12634-910-61)
1512634-910-633 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (12634-910-63)
1612634-910-666 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (12634-910-66)
1712634-910-677 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (12634-910-67)
1812634-910-699 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (12634-910-69)
1912634-910-7130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-71)
2012634-910-7424 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-74)
2112634-910-7828 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-78)
2212634-910-7925 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-79)
2312634-910-8020 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-80)
2412634-910-8121 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-81)
2512634-910-8212 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-82)
2612634-910-8414 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-84)
2712634-910-8515 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-85)
2812634-910-9090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-90)
2912634-910-911 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (12634-910-91)
3012634-910-922 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-92)
3112634-910-933 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-93)
3212634-910-944 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-94)
3312634-910-955 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-95)
3412634-910-966 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-96)
3512634-910-977 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-97)
3612634-910-988 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-98)
3712634-910-999 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (12634-910-99)

NDC Record

Field Name Field Value Definition
PRODUCT NDC12634-910The 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 NAMEPhendimetrazine TartrateThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE9/6/1977This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct 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 NUMBERNDA018074This 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.

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This page was last updated on: 12/6/2025

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