FDA.reportPublic FDA data

NDC 0069-0600-99 - PENBRAYA

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0069-0600
Requested NDC
0069-0600-99
Package NDCs from labels
0069-0600-99, 0069-0600-01, 0069-0600-05, 0069-0600-10
Manufacturer
Pfizer Laboratories Div Pfizer Inc | Pfizer Health AB | Pfizer Inc | Wyeth Pharmaceutical Division of Wyeth Holdings LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Austria GmbH | Pfizer Manufacturing Belgium NV
Effective date
2026-03-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PENBRAYAPfizer Laboratories Div Pfizer Inc | Pfizer Health AB | Pfizer Inc | Wyeth Pharmaceutical Division of Wyeth Holdings LLC | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Austria GmbH | Pfizer Manufacturing Belgium NV2026-03-17VACCINE LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
0069-0600-01These highlights do not include all the information needed to use PENBRAYA safely and effectively. See full prescribing information for PENBRAYA. PENBRAYA ® (Meningococcal Groups A, B, C, W, and Y Vaccine), suspension for intramuscular injection Initial U.S. Approval: 2023
0069-0600-01These highlights do not include all the information needed to use PENBRAYA safely and effectively. See full prescribing information for PENBRAYA. PENBRAYA ® (Meningococcal Groups A, B, C, W, and Y Vaccine), suspension for intramuscular injection Initial U.S. Approval: 2023
0069-0600-05These highlights do not include all the information needed to use PENBRAYA safely and effectively. See full prescribing information for PENBRAYA. PENBRAYA ® (Meningococcal Groups A, B, C, W, and Y Vaccine), suspension for intramuscular injection Initial U.S. Approval: 2023
0069-0600-05These highlights do not include all the information needed to use PENBRAYA safely and effectively. See full prescribing information for PENBRAYA. PENBRAYA ® (Meningococcal Groups A, B, C, W, and Y Vaccine), suspension for intramuscular injection Initial U.S. Approval: 2023
0069-0600-10These highlights do not include all the information needed to use PENBRAYA safely and effectively. See full prescribing information for PENBRAYA. PENBRAYA ® (Meningococcal Groups A, B, C, W, and Y Vaccine), suspension for intramuscular injection Initial U.S. Approval: 2023
0069-0600-10These highlights do not include all the information needed to use PENBRAYA safely and effectively. See full prescribing information for PENBRAYA. PENBRAYA ® (Meningococcal Groups A, B, C, W, and Y Vaccine), suspension for intramuscular injection Initial U.S. Approval: 2023

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-0271-01PENBRAYA0.5 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,0.5 mL5 ug in 0.5mL10
0069-0332-01PENBRAYA0.5 mL in 1 SYRINGESUSPENSION0.5 mL0.06 mg in 0.5mL10
0069-0600-01PENBRAYA1 in 1 CARTONKIT110
0069-0600-05PENBRAYA5 in 1 CARTONKIT510
0069-0600-10PENBRAYA10 in 1 CARTONKIT1010
0069-0600-99PENBRAYA1 in 1 KITKIT110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0600PENBRAYA (MENINGOCOCCAL GROUPS A, B, C, W, AND Y VACCINE) KIT [PFIZER LABORATORIES DIV PFIZER INC]7Current NDC, 6 package rows20241228_fd5652b6-5ae4-437e-a456-47deaf500794.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0600-01EA - Each0069-0600dea3d3f7-6bba-4dd0-aee9-4c934513162312023-12-05
0069-0600-05EA - Each0069-06002474c0be-5aa9-45ab-9936-f3650858376f12023-12-05
0069-0600-10EA - Each0069-06000c1cda9a-e413-4133-86c8-7c7b406ecaf212026-02-05

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 55 · 1,090 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsExact identifier
unii: 451W47IQ8X
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCbbc5b820-4973-11e2-a192-0002a5d5c51b2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCc29bdfa0-4976-11e2-939b-0002a5d5c51b2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLC515dcee0-3e34-11e2-a25f-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
Gelfos-MALUMINUM PHOSPHATE, COLLOIDAL, MAGNESIUM HYDROXIDE, SIMETHICONEMasaem Company56b9a769-08fb-738f-e063-6294a90a9eb22026-07-16WarningsExact identifier
unii: F92V3S521O
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsExact identifier
unii: 451W47IQ8X
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
unii: 451W47IQ8X
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R