NDC 0069-0600OTC monographFDA BLA · BLA125770

Penbraya

Active substance: Meningococcal groups a, b, c, w, and y vaccine

FDA labeler: Pfizer Laboratories Div Pfizer Inc

1 formulations • 6 package configurations
All 7 registered NDCs — click to copy
In one line

Penbraya (Meningococcal groups a, b, c, w, and y vaccine) NDC 0069-0600 converts to 00069-0600-01 for billing and bills under NDC-Only at Per Unit / Tablet / Capsule.

FDA Approval & Market Entry Timeline

Official openFDA & DailyMed regulatory registration sequence
Listing: 0069-0600 Verified
1. Initial Approval
2023
First U.S. FDA clearance for Meningococcal groups a, b, c, w, and y vaccine
2. FDA Application
BLA125770
Regulatory pathway: BLA
3. Market Entry Date
Nov 27, 2023
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
NDC-Only
Standard Oral / Topical Pharmacy NDC Billing (No J-Code required)
Billable unit: Per Unit / Tablet / Capsule
11-digit HIPAA NDC
00069-0600-01
Zero-padded 5-4-2 format
Standard conversion
CPT administration code
99213 / Pharmacy
Oral self-administered medication / Office Visit or Pharmacy Claim
UB-04 revenue code
Rev 0636
0636 (Pharmacy - Extension of 0250 Drugs Requiring Detail)
Qualifier: UN

Interactive Unit Multiplier Calculator

NDC-Only

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.

MG
Units to report on claim:
100 Units
Based on 1 mg = 1 billable unit (100.0 exact)
Box 24 / HCPCS Quantity Formatted Line:NDC-Only UN100 (N40069060001)
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 PENBRAYA, with 10-digit and 11-digit NDC formats
Formulation / rolePackage NDCProduct NDC11-digit HIPAAPackaging detailCopy
Outer kit carton0069-0600-010069-060000069-0600-011 KIT in 1 CARTON (0069-0600-01) / 1 KIT in 1 KIT (0069-0600-99) * .5 mL in 1 SYRINGE (0069-0332-01) * .5 mL in 1 VIAL, GLASS (0069-0271-01)
Vial component0069-0600-990069-060000069-0600-99Inner component of kit (0069-0600-01)
Vial component0069-0332-010069-060000069-0332-01Inner component of kit (0069-0600-01)
Vial component0069-0271-010069-060000069-0271-01Inner component of kit (0069-0600-01)
Outer kit carton0069-0600-050069-060000069-0600-055 KIT in 1 CARTON (0069-0600-05) / 1 KIT in 1 KIT (0069-0600-99) * .5 mL in 1 SYRINGE (0069-0332-01) * .5 mL in 1 VIAL, GLASS (0069-0271-01)
Outer kit carton0069-0600-100069-060000069-0600-1010 KIT in 1 CARTON (0069-0600-10) / 1 KIT in 1 KIT (0069-0600-99) * .5 mL in 1 SYRINGE (0069-0332-01) * .5 mL in 1 VIAL, GLASS (0069-0271-01)
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
PENBRAYA is indicated for clinical therapeutic management as active pharmaceutical therapy containing meningococcal groups a, b, c, w, and y vaccine.
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: meningococcal groups a, b, c, w, and y vaccine.
Contraindicated in patients with severe hypersensitivity to meningococcal groups a, b, c, w, and y 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.
Labeler

Pfizer Inc.

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