NDC Code(s) : 67253-580-42, 67253-580-43, 67253-580-44, 67253-580-45, 67253-580-46, 67253-580-47, 67253-580-48
Packager : Par Pharmaceutical

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Rheumatrex Methotrexate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67253-580
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHOTREXATE SODIUM(UNII: 3IG1E710ZN)
(METHOTREXATE - UNII:YL5FZ2Y5U1) 		METHOTREXATE2.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 6 mm
Flavor Imprint Code M;1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67253-580-424 in 1 CARTON 12/07/1953
12 in 1 BLISTER PACK Type 0: Not a Combination Product
2NDC:67253-580-434 in 1 CARTON 12/07/1953
23 in 1 BLISTER PACK Type 0: Not a Combination Product
3NDC:67253-580-444 in 1 CARTON 12/07/1953
34 in 1 BLISTER PACK Type 0: Not a Combination Product
4NDC:67253-580-454 in 1 CARTON 12/07/1953
45 in 1 BLISTER PACK Type 0: Not a Combination Product
5NDC:67253-580-464 in 1 CARTON 12/07/1953
56 in 1 BLISTER PACK Type 0: Not a Combination Product
6NDC:67253-580-474 in 1 CARTON 12/07/1953
67 in 1 BLISTER PACK Type 0: Not a Combination Product
7NDC:67253-580-484 in 1 CARTON 12/07/1953
78 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA008085 12/07/1953 08/31/2018

PRINCIPAL DISPLAY PANEL

Rheumatrex (methotrexate tablets, USP) blister pack front label

Rheumatrex® DOSE PACK®

(METHOTREXATE TABLETS, USP)

NDC 67253-580-46

each tablet contains an amount of methotrexate sodium equivalent to 2.5 mg of methotrexate

15 mg Per Week (6 tablets)
one week therapy

PRINCIPAL DISPLAY PANEL

Rheumatrex (methotrexate tablets, USP) blister pack back label

CAUTION: THIS IS A POTENT MEDICATION. FOLLOW THE PRESCRIBED SCHEDULE EXACTLY TO AVOID THE RISK OF POTENTIALLY SEVERE SIDE EFFECTS.

DOSAGE: See prescription label.

Rx only

Store at 20° - 25°C (68° - 77°F).

[See USP Controlled Room Temperature.]

PROTECT FROM LIGHT.

Manufactured for: DAVA Pharmaceuticals, Inc., Fort Lee, NJ 07024, USA

By: Excella GmbH, Feucht, Germany

Rev. 07/09

PRINCIPAL DISPLAY PANEL

Rheumatrex (methotrexate tablets, USP) carton label

4x6 Tablets           NDC 67253-580-46

Rheumatrex® DOSE PACK®

(METHOTREXATE TABLETS, USP)

each tablet contains an amount of methotrexate sodium equivalent to 2.5 mg of methotrexate

15 mg Per Week (6 tablets)

4 week dose pack

CAUTION: THIS IS A POTENT MEDICATION. FOLLOW THE PRESCRIBED SCHEDULE EXACTLY TO AVOID THE RISK OF POTENTIALLY SEVERE SIDE EFFECTS.

Rx only

Store at 20° - 25°C (68° - 77°F).

[See USP Controlled Room Temperature.]

PROTECT FROM LIGHT.

Manufactured for: DAVA Pharmaceuticals, Inc., Fort Lee, NJ 07024, USA

By: Excella GmbH, Feucht, Germany

Rev. 07/09

PHARMACIST: See attached circular.

PLACE PRESCRIPTION LABEL HERE.

Label should read:

Either:

Take 6 tablets in single dose. Same time, same day, each week.

or:

Take all tablets on card within a 24-hour period on the same day each week as directed by physician.