NDC Code(s) : 71205-468-30, 71205-468-60, 71205-468-90
Packager : Proficient Rx LP

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDE TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-468(NDC:68180-698)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRAMADOL HYDROCHLORIDE(UNII: 9N7R477WCK)
(TRAMADOL - UNII:39J1LGJ30J) 		TRAMADOL HYDROCHLORIDE200 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
CROSPOVIDONE(UNII: 2S7830E561)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STEARYL FUMARATE(UNII: 7CV7WJK4UI)
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape ROUND (biconvex) Size 9 mm
Flavor Imprint Code L011
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71205-468-3030 in 1 BOTTLE Type 0: Not a Combination Product13/08/2020
2NDC:71205-468-6060 in 1 BOTTLE Type 0: Not a Combination Product13/08/2020
3NDC:71205-468-9090 in 1 BOTTLE Type 0: Not a Combination Product13/08/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA200503 08/19/2014

LABELER - Proficient Rx LP(079196022)

Establishment
Name Address ID/FEI Business Operations
Proficient Rx LP 079196022 REPACK(71205-468), RELABEL(71205-468)

PRINCIPAL DISPLAY PANEL

TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS

Rx Only

200 mg

NDC 71205-468-30

30 TABLETS

71205-468-30