NDC 0069-2465OTC monographFDA BLA · BLA125769

Abrysvo

Active substance: Respiratory Syncytial Virus Vaccine

FDA labeler: Pfizer Laboratories Div Pfizer Inc

1 formulations • 3 package configurations
All 4 registered NDCs — click to copy
In one line

Abrysvo (Respiratory Syncytial Virus Vaccine) NDC 0069-2465 converts to 00069-2465-01 for billing and bills under CPT 90678 at 1 Dose = 1 Unit.

openFDA Live Registry SyncHIPAA 5-4-2 StandardCMS Level II Crosswalk
Listing: 0069-2465
Billing & reimbursement crosswalk

NDC • HCPCS Level II • CPT administration

HCPCS Level II J-Code
CPT 90678
Respiratory syncytial virus vaccine (RSV), bivalent, recombinant (0.5 mL)
Billable unit: 1 Dose = 1 Unit
11-digit HIPAA NDC
00069-2465-01
Zero-padded 5-4-2 format
Standard conversion
CPT administration code
CPT 90678
Vaccine Product Code (Respiratory syncytial virus vaccine (RSV), bivalent, recombinant (0.5 mL))
UB-04 revenue code
Rev 0636
0636 (Pharmacy - Extension of 0250 Drugs Requiring Detail)
Qualifier: ML

Interactive Unit Multiplier Calculator

CPT 90678

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.

DOSE
Units to report on claim:
100 Units
Based on 1 dose = 1 billable unit (100.0 exact)
Box 24 / HCPCS Quantity Formatted Line:CPT 90678 UN100 (N40069246501)
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All registered strengths & packaging

Every registered strength and package for Abrysvo, with 10-digit and 11-digit NDC formats
Formulation / rolePackage NDCProduct NDC11-digit HIPAAPackaging detailCopy
.06 mg/.5mL, .06 mg/.5mL0069-2465-010069-246500069-2465-011 VIAL in 1 CARTON (0069-2465-01) / .5 mL in 1 VIAL (0069-2465-19)
Vial component0069-2465-190069-246500069-2465-19Inner component of kit (0069-2465-01)
.06 mg/.5mL, .06 mg/.5mL0069-2465-100069-246500069-2465-1010 VIAL in 1 CARTON (0069-2465-10) / .5 mL in 1 VIAL (0069-2465-19)
FDA drug label

Prescribing information

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
Abrysvo is indicated for clinical therapeutic management as active pharmaceutical therapy containing RECOMBINANT STABILIZED RSV A PREFUSION F ANTIGEN (.06 mg/.5mL), RECOMBINANT STABILIZED RSV B PREFUSION F ANTIGEN (.06 mg/.5mL).
Dosage must be individualized based on clinical therapeutic goals, route of administration (INTRAMUSCULAR), and patient response. Refer to licensed physician prescribing guidelines.
Supplied as INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION. Active ingredients: RECOMBINANT STABILIZED RSV A PREFUSION F ANTIGEN (.06 mg/.5mL), RECOMBINANT STABILIZED RSV B PREFUSION F ANTIGEN (.06 mg/.5mL).
Contraindicated in patients with severe hypersensitivity to Respiratory Syncytial Virus Vaccine or formulation components.
Review complete patient medical history, potential contraindications, and drug-drug interactions prior to initiation.
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.
Billing code

Abrysvo — CPT 90678

Respiratory syncytial virus vaccine (RSV), bivalent, recombinant (0.5 mL). Billed at 1 Dose = 1 Unit.

Unit calculation
Labeler

Pfizer Inc.

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