Salsalate (Page 4 of 4)

HOW SUPPLIED

500mg Tablets: Supplied in bottles of

100ct (NDC 10135-0492-01)

500ct (NDC 10135-0492-05)

1000ct (NDC 10135-0492-10)

Appearance: Yellow colored, round, film-coated tablets debossed “AN” over “512” on one side and plain on the other.

750mg Tablets: Supplied in bottles of

100ct (NDC 10135-0493-01)

500ct (NDC 10135-0493-05)

1000ct (NDC 10135-0493-10)

Appearance: Yellow colored, capsule-shaped, scored, film-coated tablets debossed “AN 513” on one side and plain on the other.

Dispense contents with a child-resistant closure (as required) and in a tight container as defined in the USP.

Store at 20°C to 25°C (68-77°F): excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature].

Rx Only

REFERENCES

  1. Morris HG, Sherman NA, McQuain C, et al: Effects of Salsalate (Non- Acetylated Salicylate) and Aspirin (ASA) on Serum Prostaglandins in Humans. Ther. Drug Monit. 7:435-438, 1985.
  2. April PA, Curran NJ, Ekohlm BP, et al: Multicenter Comparative Study of Salsalate (SSA) vs Aspirin (ASA) in Rheumatoid Arthritis (RA), Arthritis Rheumatism 30 (4 supplement):S93, 1987.
  3. Deodhar SD, McLeod MM, Dick WC, et al: A Short-Term Comparative Trial of Salsalate and Indomethacin in Rheumatoid Arthritis. Curr. Med. Res. Opin., 5:185-188,1977.
  4. Estes D, Kaplan K: Lack of Platelet Effect With the Aspirin Analog, Salsalate, Arthritis and Rheumatism, 23:1303-1307, 1980.
  5. Dick C, Dick PH, Nuki G, et al: Effect of Anti-inflammatory Drug Therapy on Clearance of 133Xe from Knee Joints of Patients with Rheumatoid Arthritis. British Med. J. 3:278-280, 1969.
  6. Dick WC, Grayson MF, Woodburn A, et al: Indices of Inflammatory Activity. Ann. of the Rheum. Dis. 29:643-648, 1970.
  7. Cohen A:Fecal Blood Loss and Plasma Salicylate Study of Salicylsalicylic Acid and Aspirin. J. Clin. Pharmacol. 19:242-247, 1979.
  8. Chudwin DS, Strub M. Golden HE, et al: Sensitivity to Non-Acetylated Salicylates in a Patient with Asthma, Nasal Polyps, and Rheumatoid Arthritis. Annals of Allergy 57:133-134, 1986.
  9. Spector SL, Wangaard CH, Farr RS: Aspirin and Concomitant Idiosyncrasies in Adult Asthmatic Patients. J. Allergy Clin. Immunol 64:500-506, 1979.
  10. Stevenson DD, Schrank PJ, Hougham AJ, et al: Salsalate Cross Sensitivity in Aspirin-Sensitive Asthmatics. J. Allergy Clin. Immunol 81:181, 1988.

Manufactured by:
Amneal Pharmaceuticals
Paterson, NJ 07504

Distributed by:
Marlex Pharmaceuticals, Inc.
50 McCullough DriveNew Castle, DE 19720

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma — TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count750 mg
6067544-410-53
9067544-410-60
12067544-410-70
18067544-410-80
27067544-410-92
36067544-410-94

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions -- TN
Cookeville, TN 38506
20171220DKJ

PRINCIPAL DISPLAY PANEL — 750mg

NDC 67544-0410 Salsalate 750mg — Rx OnlyBottle Label 750mg

SALSALATE salsalate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67544-410(NDC:10135-493)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALSALATE (SALSALATE) SALSALATE 750 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
STEARIC ACID
TITANIUM DIOXIDE
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code AN;513
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67544-410-53 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:67544-410-60 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:67544-410-70 120 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:67544-410-80 180 TABLET, FILM COATED in 1 BOTTLE None
5 NDC:67544-410-92 270 TABLET, FILM COATED in 1 BOTTLE None
6 NDC:67544-410-94 360 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 04/01/2007
Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (67544-410)

Revised: 12/2017 Aphena Pharma Solutions — Tennessee, LLC

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