NDC 58160-823OTC monographFDA BLA · BLA125614

Shingrix

Active substance: Zoster Vaccine Recombinant, Adjuvanted

FDA labeler: GlaxoSmithKline Biologicals SA

3 formulations • 6 package configurations
All 9 registered NDCs — click to copy
In one line

Shingrix (Zoster Vaccine Recombinant, Adjuvanted) NDC 58160-823 converts to 58160-0823-11 for billing and bills under CPT 90750 at 1 Dose = 1 Unit.

FDA Approval & Market Entry Timeline

Official openFDA & DailyMed regulatory registration sequence
Listing: 58160-823 Verified
1. Initial Approval
2017
First U.S. FDA clearance for Zoster Vaccine Recombinant, Adjuvanted
2. FDA Application
BLA125614
Regulatory pathway: BLA
3. Market Entry Date
Oct 20, 2017
First commercial NDC distribution & launch date
4. Regulatory Status
Active Commercial Listing
Registration valid through Dec 31, 2027
Billing & reimbursement crosswalk

NDC • HCPCS Level II • CPT administration

HCPCS Level II J-Code
CPT 90750
Zoster (shingles) vaccine recombinant, adjuvanted (0.5 mL)
Billable unit: 1 Dose = 1 Unit
11-digit HIPAA NDC
58160-0823-11
Zero-padded 5-4-2 format
Standard conversion
CPT administration code
CPT 90750
Vaccine Product Code (Zoster (shingles) vaccine recombinant, adjuvanted (0.5 mL))
UB-04 revenue code
Rev 0636
0636 (Pharmacy - Extension of 0250 Drugs Requiring Detail)
Qualifier: UN

Interactive Unit Multiplier Calculator

CPT 90750

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 90750 UN100 (N45816082311)
Always verify NDC package code, billable multiplier, and invoice qualifier with specific payer guidelines before claim filing.
Complete drug registry

All registered strengths & packaging

Every registered strength and package for Shingrix, with 10-digit and 11-digit NDC formats
Formulation / rolePackage NDCProduct NDC11-digit HIPAAPackaging detailCopy
Outer kit carton58160-823-1158160-82358160-0823-111 KIT in 1 CARTON (58160-823-11) * .5 mL in 1 VIAL (58160-828-03) * .5 mL in 1 VIAL (58160-829-03)
Vial component58160-828-0358160-82358160-0828-03Inner component of kit (58160-823-11)
Vial component58160-829-0358160-82358160-0829-03Inner component of kit (58160-823-11)
50 ug/.5mL58160-849-5258160-84958160-0849-5210 SYRINGE in 1 CARTON (58160-849-52) / .5 mL in 1 SYRINGE (58160-849-43)
Prefilled syringe58160-849-4358160-84958160-0849-43Inner component of kit (58160-849-52)
50 ug/.5mL50090-7919-050090-791950090-7919-001 mL in 1 KIT (50090-7919-0)
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
Shingrix is indicated for clinical therapeutic management as active pharmaceutical therapy containing Zoster Vaccine Recombinant, Adjuvanted.
Dosage must be individualized based on clinical therapeutic goals, route of administration (Standard Administration), and patient response. Refer to licensed physician prescribing guidelines.
Supplied as KIT. Active ingredients: Zoster Vaccine Recombinant, Adjuvanted.
Contraindicated in patients with severe hypersensitivity to Zoster Vaccine Recombinant, Adjuvanted or formulation components.
Review complete patient medical history, potential contraindications, and drug-drug interactions prior to initiation.
Supplied under FDA Labeler: GlaxoSmithKline Biologicals SA. Store according to manufacturer packaging specifications at controlled room temperature or refrigerated conditions as marked on commercial carton.
Billing code

Shingrix — CPT 90750

Zoster (shingles) vaccine recombinant, adjuvanted (0.5 mL). Billed at 1 Dose = 1 Unit.

Unit calculation
Terms used here11-digit NDCBillable unitN4 qualifier
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