Hydrocortisone Sodium Succinate Injection
NDC Package 69097-004-67
Package Information
Hydrocortisone Sodium Succinate injection is when oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of hydrocortisone sodium succinate for injection is indicated as follows:Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions.Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of 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 thyroiditis.Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis.Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia.Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy.Neoplastic diseases: For the palliative management of leukemias and lymphomas.Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy.Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids.Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus.Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). This formulation utilizes a injection delivery system. Marketed by Cipla Usa Inc., this product is identified by NDC 69097-004 and is authorized under FDA application ANDA214050.
Identification & Billing
- RxCUI: 238755 - hydrocortisone sodium succinate 100 MG Injection
- RxCUI: 238755 - hydrocortisone 100 MG Injection
- RxCUI: 238755 - hydrocortisone (as hydrocortisone sodium succinate) 100 MG Injection
Clinical Specifications
- Intramuscular - Administration within a muscle.
- Intravenous - Administration within or into a vein or veins.
Regulatory & Marketing
Hierarchy Structure
- 69097 - Cipla Usa Inc.
- 69097-004 - Hydrocortisone Sodium Succinate
- 69097-004-67 - 1 VIAL in 1 CARTON / 2 mL in 1 VIAL
- 69097-004 - Hydrocortisone Sodium Succinate
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.
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Billing & HCPCS Mapping
To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.
Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.
* 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 69097-004-67 identifies a specific commercial package of 1 vial in 1 carton / 2 ml in 1 vial of Hydrocortisone Sodium Succinate, a human prescription drug labeled by Cipla Usa Inc.. This injection is formulated for intramuscular; intravenous use and contains hydrocortisone sodium succinate 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 Cipla Usa Inc. on September 25, 2024. The current certification is valid through December 31, 2026.
How is this Cipla Usa Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 69097000467. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.