Cephalexin (Page 4 of 4)

HOW SUPPLIED

Cephalexin capsules USP—

250 mg: bottles of 40 (NDC 60429-036-40) and 500 (NDC 60429-036-05). Capsule identification number and color: “TEVA” — “3145”, gray cap and Swedish orange body.

500 mg: bottles of 40 (60429-037-40) and 500 (NDC 60429-037-05). Capsule identification number and color: “TEVA” — “3147”, Swedish orange cap and body.

Storage

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

REFERENCES

  1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically — Fourth Edition. Approved Standard NCCLS Document M7-A4, Vol. 17, No. 2, NCCLS, Wayne, PA, January, 1997.
  2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests — Sixth Edition. Approved Standard NCCLS Document M2-A6, Vol. 17, No. 1, NCCLS, Wayne, PA, January, 1997.
  3. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Susceptibility Testing — Eighth Informational Supplement. Approved Standard NCCLS Document M100-S8, Vol. 18, No. 1, NCCLS, Wayne, PA, January, 1998.

Manufactured by: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960

Marketed/Packaged by: GSMS Inc. Camarillo, CA 93012

Rev. P 3/2011

PRINCIPAL DISPLAY PANEL

Label Grphic -- 250 mg
(click image for full-size original)

Cephalexin Capsules USP 250 mg 500s Label Text

NDC 60429-036-05

CEPHALEXIN

Capsules USP

250 mg*

Rx only

500 CAPSULES

PRINCIPAL DISPLAY PANEL

Label Graphic -- 500mg
(click image for full-size original)

Cephalexin Capsules USP 500 mg 500s Label Text

NDC 60429-037-05

CEPHALEXIN

Capsules USP

500 mg*

Rx only

500 CAPSULES

CEPHALEXIN
cephalexin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-036(NDC:0093-3145)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEPHALEXIN (CEPHALEXIN ANHYDROUS) CEPHALEXIN ANHYDROUS 250 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
FERROSOFERRIC OXIDE
D&C YELLOW NO. 10
ALUMINUM OXIDE
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
PROPYLENE GLYCOL
FERRIC OXIDE YELLOW
Product Characteristics
Color GRAY, ORANGE (swedish orange) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code TEVA;3145
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-036-40 40 CAPSULE in 1 BOTTLE None
2 NDC:60429-036-05 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062702 01/28/2011
CEPHALEXIN
cephalexin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-037(NDC:0093-3147)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEPHALEXIN (CEPHALEXIN ANHYDROUS) CEPHALEXIN ANHYDROUS 500 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
FERROSOFERRIC OXIDE
D&C YELLOW NO. 10
ALUMINUM OXIDE
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
PROPYLENE GLYCOL
Product Characteristics
Color ORANGE (swedish orange) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code TEVA;3147
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-037-40 40 CAPSULE in 1 BOTTLE None
2 NDC:60429-037-05 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062702 01/28/2011
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 REPACK (60429-036), REPACK (60429-037), RELABEL (60429-036), RELABEL (60429-037)

Revised: 07/2011 Golden State Medical Supply, Inc.

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