71610-006 NDC - TRAMADOL HYDROCHLORIDE

Drug Information

Product NDC: 71610-006

Proprietary Name: Tramadol Hydrochloride

Non Proprietary Name: Tramadol Hydrochloride

Active Ingredient(s):

50 mg/1 TRAMADOL HYDROCHLORIDE

Administration Route(s): ORAL

Dosage Form(s): TABLET, FILM COATED

Pharmacy Class(es):

Full Opioid Agonists [MoA];
Opioid Agonist [EPC]

Labeler Information

Labeler Name:	Aphena Pharma Solutions - Tennessee, LLC
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:	ANDA075977
Marketing Category:	ANDA
Start Marketing Date:	8/24/2017
DEA Schedule:	CIV

Package Information

No.	Package Code	Package Description	Billing Unit
1	71610-006-15	15 TABLET, FILM COATED in 1 BOTTLE (71610-006-15)	EA
2	71610-006-20	20 TABLET, FILM COATED in 1 BOTTLE (71610-006-20)	EA
3	71610-006-24	224 TABLET, FILM COATED in 1 BOTTLE (71610-006-24)	EA
4	71610-006-28	28 TABLET, FILM COATED in 1 BOTTLE (71610-006-28)	EA
5	71610-006-30	30 TABLET, FILM COATED in 1 BOTTLE (71610-006-30)	EA
6	71610-006-40	40 TABLET, FILM COATED in 1 BOTTLE (71610-006-40)	EA
7	71610-006-45	45 TABLET, FILM COATED in 1 BOTTLE (71610-006-45)	EA
8	71610-006-46	56 TABLET, FILM COATED in 1 BOTTLE (71610-006-46)	EA
9	71610-006-48	480 TABLET, FILM COATED in 1 BOTTLE (71610-006-48)	EA
10	71610-006-50	50 TABLET, FILM COATED in 1 BOTTLE (71610-006-50)	EA
11	71610-006-53	60 TABLET, FILM COATED in 1 BOTTLE (71610-006-53)	EA
12	71610-006-54	84 TABLET, FILM COATED in 1 BOTTLE (71610-006-54)	EA
13	71610-006-57	80 TABLET, FILM COATED in 1 BOTTLE (71610-006-57)	EA
14	71610-006-60	90 TABLET, FILM COATED in 1 BOTTLE (71610-006-60)	EA
15	71610-006-65	100 TABLET, FILM COATED in 1 BOTTLE (71610-006-65)	EA
16	71610-006-67	168 TABLET, FILM COATED in 1 BOTTLE (71610-006-67)	EA
17	71610-006-70	120 TABLET, FILM COATED in 1 BOTTLE (71610-006-70)	EA
18	71610-006-72	112 TABLET, FILM COATED in 1 BOTTLE (71610-006-72)	EA
19	71610-006-73	135 TABLET, FILM COATED in 1 BOTTLE (71610-006-73)	EA
20	71610-006-75	150 TABLET, FILM COATED in 1 BOTTLE (71610-006-75)	EA
21	71610-006-80	180 TABLET, FILM COATED in 1 BOTTLE (71610-006-80)	EA
22	71610-006-85	200 TABLET, FILM COATED in 1 BOTTLE (71610-006-85)	EA
23	71610-006-89	720 TABLET, FILM COATED in 1 BOTTLE (71610-006-89)	EA
24	71610-006-90	240 TABLET, FILM COATED in 1 BOTTLE (71610-006-90)	EA
25	71610-006-92	270 TABLET, FILM COATED in 1 BOTTLE (71610-006-92)	EA
26	71610-006-94	360 TABLET, FILM COATED in 1 BOTTLE (71610-006-94)	EA
27	71610-006-98	540 TABLET, FILM COATED in 1 BOTTLE (71610-006-98)	EA

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	71610-006	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.
PRODUCT TYPE NAME	HUMAN PRESCRIPTION DRUG	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
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.
NON PROPRIETARY NAME	Tramadol Hydrochloride	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	TABLET, FILM COATED	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	8/24/2017	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	ANDA	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	ANDA075977	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	Aphena Pharma Solutions - Tennessee, LLC	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	TRAMADOL HYDROCHLORIDE	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	50
ACTIVE INGRED UNIT	mg/1
PHARM CLASSES	Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA SCHEDULE	CIV	This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

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This page was last updated on: 2/1/2023

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