Prednisone Tablet
NDC Package 71335-3129-1

11-digit billing NDC: 71335312901
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Prednisone tablets are indicated in the following conditions:1. This formulation utilizes a tablet delivery system. Marketed by Bryant Ranch Prepack, this product is identified by NDC 71335-3129 and is authorized under FDA application ANDA040584.

Identification & Billing

NDC Package Code
71335-3129-1
Package Description
100 TABLET in 1 BOTTLE
Product Code
71335-3129
11-Digit Billing Format
71335312901
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Prednisone
Non-Proprietary Name
Prednisone
Substance Name
Prednisone
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PREDNISONE 1 mg/1
Pharmacologic Class
Usage Information
PredniSONE Tablets are indicated in the following conditions:1. Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Hypercalcemia associated with cancer Nonsuppurative thyroiditis2. Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis3. Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:Systemic lupus erythematosus Systemic dermatomyositis (polymyositis)Acute rheumatic carditis4. Dermatologic DiseasesPemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis5. Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventionaltreatment:Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions6. Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:Allergic corneal marginal ulcersHerpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis7. Respiratory DiseasesSymptomatic sarcoidosis Loeffler’s syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis 8. Hematologic DisordersIdiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia9. Neoplastic DiseasesFor palliative management of:Leukemias and lymphomas in adults Acute leukemia of childhood10. Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of theidiopathic type or that due to lupus erythematosus11. Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:Ulcerative colitis Regional enteritis12. MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.Trichinosis with neurologic or myocardial involvement

Regulatory & Marketing

Labeler Name
Bryant Ranch Prepack
Product Type
Human Prescription Drug
FDA Application #
ANDA040584
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-21-2004
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (71335-3129). Click a package code to view its specific billing and regulatory data.

71335-3129-2
30 TABLET in 1 BOTTLE, PLASTIC

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 71335-3129-1 identifies a specific commercial package of 100 tablet in 1 bottle of Prednisone, a human prescription drug labeled by Bryant Ranch Prepack. This tablet is formulated for oral use and contains prednisone as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Bryant Ranch Prepack on December 21, 2004. The current certification is valid through December 31, 2027.

How is this Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71335312901. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
71335-3129-1
11-Digit CMS (5-4-2)
71335-3129-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.