NDC 0069-8476OTC monographFDA BLA · BLA125062

Octagam Immune Globulin (Human)

Active substance: Immune Globulin

FDA labeler: Pfizer Laboratories Div Pfizer Inc

11 formulations • 28 package configurations

All 39 registered NDCs — click to copy

In one line

Octagam Immune Globulin (Human) (Immune Globulin) NDC 0069-8476 converts to 00069-8476-02 for billing and bills under J3590 at Per Administration.

openFDA Live Registry SyncHIPAA 5-4-2 StandardCMS Level II Crosswalk

Listing: 0069-8476

Billing & reimbursement crosswalk

NDC • HCPCS Level II • CPT administration

HCPCS Level II J-Code

J3590

Unclassified biologics (requires invoice & NDC on claim)

Billable unit: Per Administration

11-digit HIPAA NDC

00069-8476-02

Zero-padded 5-4-2 format

Standard conversion

CPT administration code

96413

Chemotherapy / Complex Biologic IV Infusion, initial up to 1 hour

UB-04 revenue code

Rev 0636

0636 (Pharmacy - Extension of 0250 Drugs Requiring Detail)

Qualifier: ML

Interactive Unit Multiplier Calculator

J3590

Calculate the exact number of billable HCPCS units to report on CMS-1500 / 837P claims based on the patient dose and single-dose vial waste.

Administered Patient Dose

Units to report on claim:

100 Units

Based on 1 mg = 1 billable unit (100.0 exact)

Box 24 / HCPCS Quantity Formatted Line:J3590 UN100 (N40069847602)

Every registered strength and package for Octagam Immune Globulin (Human), with 10-digit and 11-digit NDC formats
Formulation / role	Package NDC	Product NDC	11-digit HIPAA	Packaging detail
50 mg/mL	0069-8476-02	0069-8476	00069-8476-02	1 BOTTLE, GLASS in 1 CARTON (0069-8476-02) / 200 mL in 1 BOTTLE, GLASS (0069-8476-01)
Inner component	0069-8476-01	0069-8476	00069-8476-01	Inner component of kit (0069-8476-02)
50 mg/mL	0069-8425-02	0069-8425	00069-8425-02	1 BOTTLE, GLASS in 1 CARTON (0069-8425-02) / 50 mL in 1 BOTTLE, GLASS (0069-8425-01)
Inner component	0069-8425-01	0069-8425	00069-8425-01	Inner component of kit (0069-8425-02)
100 mg/mL	0069-6002-02	0069-6002	00069-6002-02	1 BOTTLE, GLASS in 1 CARTON (0069-6002-02) / 20 mL in 1 BOTTLE, GLASS (0069-6002-01)
Inner component	0069-6002-01	0069-6002	00069-6002-01	Inner component of kit (0069-6002-02)
50 mg/mL	68982-840-01	68982-840	68982-0840-01	20 mL in 1 BOTTLE, GLASS (68982-840-01)
50 mg/mL	68982-840-02	68982-840	68982-0840-02	50 mL in 1 BOTTLE, GLASS (68982-840-02)
50 mg/mL	68982-840-03	68982-840	68982-0840-03	100 mL in 1 BOTTLE, GLASS (68982-840-03)
50 mg/mL	68982-840-04	68982-840	68982-0840-04	200 mL in 1 BOTTLE, GLASS (68982-840-04)
50 mg/mL	68982-840-05	68982-840	68982-0840-05	500 mL in 1 BOTTLE, GLASS (68982-840-05)
100 mg/mL	68982-850-01	68982-850	68982-0850-01	20 mL in 1 BOTTLE, GLASS (68982-850-01)
100 mg/mL	68982-850-02	68982-850	68982-0850-02	50 mL in 1 BOTTLE, GLASS (68982-850-02)
100 mg/mL	68982-850-03	68982-850	68982-0850-03	100 mL in 1 BOTTLE, GLASS (68982-850-03)
100 mg/mL	68982-850-04	68982-850	68982-0850-04	200 mL in 1 BOTTLE, GLASS (68982-850-04)
100 mg/mL	68982-850-05	68982-850	68982-0850-05	300 mL in 1 BOTTLE, GLASS (68982-850-05)
100 mg/mL	0069-6339-02	0069-6339	00069-6339-02	1 BOTTLE, GLASS in 1 CARTON (0069-6339-02) / 300 mL in 1 BOTTLE, GLASS (0069-6339-01)
Inner component	0069-6339-01	0069-6339	00069-6339-01	Inner component of kit (0069-6339-02)
100 mg/mL	0069-6237-02	0069-6237	00069-6237-02	1 BOTTLE, GLASS in 1 CARTON (0069-6237-02) / 200 mL in 1 BOTTLE, GLASS (0069-6237-01)
Inner component	0069-6237-01	0069-6237	00069-6237-01	Inner component of kit (0069-6237-02)
50 mg/mL	0069-8451-02	0069-8451	00069-8451-02	1 BOTTLE, GLASS in 1 CARTON (0069-8451-02) / 100 mL in 1 BOTTLE, GLASS (0069-8451-01)
Inner component	0069-8451-01	0069-8451	00069-8451-01	Inner component of kit (0069-8451-02)
100 mg/mL	0069-6111-02	0069-6111	00069-6111-02	1 BOTTLE, GLASS in 1 CARTON (0069-6111-02) / 100 mL in 1 BOTTLE, GLASS (0069-6111-01)
Inner component	0069-6111-01	0069-6111	00069-6111-01	Inner component of kit (0069-6111-02)
50 mg/mL	0069-8400-02	0069-8400	00069-8400-02	1 BOTTLE, GLASS in 1 CARTON (0069-8400-02) / 20 mL in 1 BOTTLE, GLASS (0069-8400-01)
Inner component	0069-8400-01	0069-8400	00069-8400-01	Inner component of kit (0069-8400-02)
100 mg/mL	0069-6550-02	0069-6550	00069-6550-02	1 BOTTLE, GLASS in 1 CARTON (0069-6550-02) / 50 mL in 1 BOTTLE, GLASS (0069-6550-01)
Inner component	0069-6550-01	0069-6550	00069-6550-01	Inner component of kit (0069-6550-02)

No Structured Product Labeling submission was returned for this listing, so the sections below are derived from its FDA registration record rather than the manufacturer's label.

6 Label Sections

INDICATIONS AND USAGE

Octagam Immune Globulin (Human) is indicated for clinical therapeutic management as active pharmaceutical therapy containing HUMAN IMMUNOGLOBULIN G (50 mg/mL).

DOSAGE AND ADMINISTRATION

Dosage must be individualized based on clinical therapeutic goals, route of administration (INTRAVENOUS), and patient response. Refer to licensed physician prescribing guidelines.

DOSAGE FORMS AND STRENGTHS

Supplied as SOLUTION. Active ingredients: HUMAN IMMUNOGLOBULIN G (50 mg/mL).

CONTRAINDICATIONS

Contraindicated in patients with severe hypersensitivity to Immune Globulin or formulation components.

WARNINGS AND PRECAUTIONS

Review complete patient medical history, potential contraindications, and drug-drug interactions prior to initiation.

HOW SUPPLIED / STORAGE AND HANDLING

Supplied under FDA Labeler: Pfizer Laboratories Div Pfizer Inc. Store according to manufacturer packaging specifications at controlled room temperature or refrigerated conditions as marked on commercial carton.

Labeler

Pfizer Inc.

Full NDC portfolio, brand list and J-code coverage for this manufacturer.

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Pharmacologic class

Antigen Neutralization

Every other National Drug Code registered in the same established class.

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Terms used here11-digit NDC Billable unit N4 qualifier

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NDC • HCPCS Level II • CPT administration

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Prescribing information

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Pfizer Inc.

Antigen Neutralization