76519-1009 NDC - TRAMADOL HYDROCHLORIDE ()

Drug Information

Product NDC: 76519-1009
Proprietary Name: Tramadol Hydrochloride
Non Proprietary Name:
Active Ingredient(s):
Administration Route(s):
Dosage Form(s):

Labeler Information

Field Name	Field Value
Labeler Name:	H.J. Harkins Company, Inc.
Product Type:
FDA Application Number:	NDA022370
Marketing Category:	NDA
Start Marketing Date:	3/14/2012

Package Information

No.	Package Code	Package Description	Billing Unit
1	76519-1009-3	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (76519-1009-3)
2	76519-1009-5	15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (76519-1009-5)
3	76519-1009-6	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (76519-1009-6)
4	76519-1009-9	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (76519-1009-9)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	76519-1009	The 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 NAME	Tramadol Hydrochloride	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE	3/14/2012	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	NDA	Product 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 NUMBER	NDA022370	This 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 NAME	H.J. Harkins Company, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 7/4/2025

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