Penicillamine (Page 4 of 4)

HOW SUPPLIED

Penicillamine Capsules USP, 250 mg are white to off white colored granular powder filled in size-1 hard gelatin capsules with opaque white colored cap imprinted with ‘RDY’ with black ink and opaque white color body imprinted with ‘634’ with black ink.

They are supplied as follows:

Bottles of 100 NDC 43598-634-01

Storage

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

Keep container tightly closed.

** For quantitative test for serum ceruloplasmin see: Morell, A.G.; Windsor, J.; Sternlieb, I.; Scheinberg, I.H.: Measurement of the concentration of ceruloplasmin in serum by determination of its oxidase activity, in “Laboratory Diagnosis of Liver Disease”, F.W. Sunderman; F.W. Sunderman, Jr. (eds.), St. Louis, Warren H. Green, Inc., 1968, pp. 193-195.

*** Scheinberg, I.H.; Sternlieb, I.: N. Engl. J. Med. 293: 1300-1302, Dec. 18, 1975.

† Lotz, M.; Potts, J.T. and Bartter, F.C.: Brit. Med. J. 2: 521, Aug. 28, 1965 (in Medical Memoranda).

Rx only

Distributor:

Dr. Reddy’s Laboratories Inc.,

Princeton, NJ 08540

Made in India

Issued: 0818

Penicillamine Capsules USP, 250 mg — Container Label

container
(click image for full-size original)
PENICILLAMINE
penicillamine capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-634
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Penicillamine (Penicillamine) Penicillamine 250 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
Gelatin
Microcrystalline Cellulose
Magnesium Stearate
Titanium Dioxide
Ferrosoferric Oxide
Potassium Hydroxide
Propylene Glycol
Shellac
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code RDY;634
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-634-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211867 08/04/2020
Labeler — Dr. Reddy’s Laboratories Inc. (802315887)
Establishment
Name Address ID/FEI Operations
Dr. Reddy’s Laboratories Limited FTO-Sez-Process Unit-01 860037244 analysis (43598-634), manufacture (43598-634)

Revised: 08/2020 Dr. Reddy’s Laboratories Inc.

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