Doxycycline (Page 4 of 4)

REFERENCES

1. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twentyfifth Informational Supplement , CLSI document M100-S25. Clinical and Laboratory Standards Institute, 950 West Valley Road,Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

2. Clinical and Laboratory Standards Institute. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard — 10th ed. CLSI document M07- A10. Clinical and Laboratory Standards Institute, 950 WestValley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

3. Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard 11th ed. CLSI document M02-A12. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500,Wayne, Pennsylvania 19087, USA, 2015.

4. Clinical and Laboratory Standards Institute. Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline—Second Edition. CLSI document M45-A2. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2010.

5. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard Eighth Edition. CLSI document M11-A8. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, PA 19087 USA, 2012.

6. Clinical and Laboratory Standards Institute. Susceptibility Testing of Mycobacteria , Nocardiae , and Other Aerobic Actinomycetes; Approved Standard—Second Edition. CLSI document M24-A2. Clinical and Laboratory Standards Institute, 950West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA. 2011.

7. Clinical and Laboratory Standards Institute. Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline. CLSI document M43-A. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500,Wayne, Pennsylvania 19087, USA. 2011.

Rx only

Manufactured by:

Novel Laboratories, Inc.

400 Campus Drive

Somerset, NJ0887

PI7920000104

Revised: 02/2016

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Doxycycline Capsules, USP 50 mg

50 count

C:\Users\kvyas\Desktop\spl\50-50.jpg
(click image for full-size original)

Doxycycline Capsules, USP 75 mg

100 count

C:\Users\kvyas\Desktop\spl\75-100.jpg
(click image for full-size original)

Doxycycline Capsules, USP 100 mg

1000 count

C:\Users\kvyas\Desktop\spl\100-1000.jpg
(click image for full-size original)
DOXYCYCLINE doxycycline capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40032-790
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
FD&C RED NO. 3
D&C YELLOW NO. 10
GELATIN
SODIUM LAURYL SULFATE
SHELLAC
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
BROWN IRON OXIDE
Product Characteristics
Color YELLOW (Opaque Cap) , WHITE (Opaque Body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code NL790;50mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:40032-790-11 50 CAPSULE in 1 BOTTLE None
2 NDC:40032-790-01 100 CAPSULE in 1 BOTTLE None
3 NDC:40032-790-10 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204446 05/28/2015
DOXYCYCLINE doxycycline capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40032-791
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 75 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
GELATIN
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
SHELLAC
POTASSIUM HYDROXIDE
BROWN IRON OXIDE
Product Characteristics
Color WHITE (Opaque Body) , BROWN (Opaque Cap) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code NL791;75mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:40032-791-11 50 CAPSULE in 1 BOTTLE None
2 NDC:40032-791-01 100 CAPSULE in 1 BOTTLE None
3 NDC:40032-791-10 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204446 05/28/2015
DOXYCYCLINE doxycycline capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40032-792
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FD&C RED NO. 3
D&C YELLOW NO. 10
TITANIUM DIOXIDE
GELATIN
SODIUM LAURYL SULFATE
SHELLAC
POTASSIUM HYDROXIDE
BROWN IRON OXIDE
Product Characteristics
Color YELLOW (Opaque Body) , BROWN (Opaque Cap) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code NL792;100mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:40032-792-11 50 CAPSULE in 1 BOTTLE None
2 NDC:40032-792-12 250 CAPSULE in 1 BOTTLE None
3 NDC:40032-792-10 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204446 05/28/2015
Labeler — Novel Laboratories, Inc. (793518643)
Registrant — Novel Laboratories, Inc. (793518643)
Establishment
Name Address ID/FEI Operations
Novel Laboratories, Inc. 793518643 ANALYSIS (40032-790), ANALYSIS (40032-791), ANALYSIS (40032-792), MANUFACTURE (40032-790), MANUFACTURE (40032-791), MANUFACTURE (40032-792)

Revised: 12/2019 Novel Laboratories, Inc.

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