NDC 0069-1312OTC monographFDA BLA · BLA125587

Panzyga

Active substance: Immune globulin intravenous (human)

FDA labeler: Pfizer Laboratories Div Pfizer Inc

7 formulations • 24 package configurations

All 31 registered NDCs — click to copy

In one line

Panzyga (Immune globulin intravenous (human)) NDC 0069-1312 converts to 00069-1312-02 for billing and bills under J3590 at Per Administration.

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

Listing: 0069-1312

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

00069-1312-02

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 (N40069131202)

Every registered strength and package for Panzyga, with 10-digit and 11-digit NDC formats
Formulation / role	Package NDC	Product NDC	11-digit HIPAA	Packaging detail
100 mg/mL	0069-1224-02	0069-1224	00069-1224-02	1 BOTTLE, GLASS in 1 CARTON (0069-1224-02) / 50 mL in 1 BOTTLE, GLASS (0069-1224-01)
Inner component	0069-1224-01	0069-1224	00069-1224-01	Inner component of kit (0069-1224-02)
100 mg/mL	0069-1312-02	0069-1312	00069-1312-02	1 BOTTLE, GLASS in 1 CARTON (0069-1312-02) / 100 mL in 1 BOTTLE, GLASS (0069-1312-01)
Inner component	0069-1312-01	0069-1312	00069-1312-01	Inner component of kit (0069-1312-02)
100 mg/mL	0069-1558-02	0069-1558	00069-1558-02	1 BOTTLE, GLASS in 1 CARTON (0069-1558-02) / 300 mL in 1 BOTTLE, GLASS (0069-1558-01)
Inner component	0069-1558-01	0069-1558	00069-1558-01	Inner component of kit (0069-1558-02)
100 mg/mL	68982-822-01	68982-822	68982-0822-01	1 BOTTLE, GLASS in 1 CARTON (68982-822-01) / 10 mL in 1 BOTTLE, GLASS (68982-822-81)
Inner component	68982-822-81	68982-822	68982-0822-81	Inner component of kit (68982-822-01)
100 mg/mL	68982-822-02	68982-822	68982-0822-02	1 BOTTLE, GLASS in 1 CARTON (68982-822-02) / 25 mL in 1 BOTTLE, GLASS (68982-822-82)
Inner component	68982-822-82	68982-822	68982-0822-82	Inner component of kit (68982-822-02)
100 mg/mL	68982-822-03	68982-822	68982-0822-03	1 BOTTLE, GLASS in 1 CARTON (68982-822-03) / 50 mL in 1 BOTTLE, GLASS (68982-822-83)
Inner component	68982-822-83	68982-822	68982-0822-83	Inner component of kit (68982-822-03)
100 mg/mL	68982-822-04	68982-822	68982-0822-04	1 BOTTLE, GLASS in 1 CARTON (68982-822-04) / 100 mL in 1 BOTTLE, GLASS (68982-822-84)
Inner component	68982-822-84	68982-822	68982-0822-84	Inner component of kit (68982-822-04)
100 mg/mL	68982-822-05	68982-822	68982-0822-05	1 BOTTLE, GLASS in 1 CARTON (68982-822-05) / 200 mL in 1 BOTTLE, GLASS (68982-822-85)
Inner component	68982-822-85	68982-822	68982-0822-85	Inner component of kit (68982-822-05)
100 mg/mL	68982-822-06	68982-822	68982-0822-06	1 BOTTLE, GLASS in 1 CARTON (68982-822-06) / 300 mL in 1 BOTTLE, GLASS (68982-822-86)
Inner component	68982-822-86	68982-822	68982-0822-86	Inner component of kit (68982-822-06)
100 mg/mL	0069-1109-02	0069-1109	00069-1109-02	1 BOTTLE, GLASS in 1 CARTON (0069-1109-02) / 25 mL in 1 BOTTLE, GLASS (0069-1109-01)
Inner component	0069-1109-01	0069-1109	00069-1109-01	Inner component of kit (0069-1109-02)
100 mg/mL	0069-1415-02	0069-1415	00069-1415-02	1 BOTTLE, GLASS in 1 CARTON (0069-1415-02) / 200 mL in 1 BOTTLE, GLASS (0069-1415-01)
Inner component	0069-1415-01	0069-1415	00069-1415-01	Inner component of kit (0069-1415-02)
100 mg/mL	0069-1011-02	0069-1011	00069-1011-02	1 BOTTLE, GLASS in 1 CARTON (0069-1011-02) / 10 mL in 1 BOTTLE, GLASS (0069-1011-01)
Inner component	0069-1011-01	0069-1011	00069-1011-01	Inner component of kit (0069-1011-02)

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

Panzyga is indicated for clinical therapeutic management as active pharmaceutical therapy containing HUMAN IMMUNOGLOBULIN G (100 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 (100 mg/mL).

CONTRAINDICATIONS

Contraindicated in patients with severe hypersensitivity to immune globulin intravenous (human) 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.

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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

Related

Pfizer Inc.

Antigen Neutralization