FDA.reportPublic FDA data

National Council for Prescription Drug Programs indexing - billing unit

Manufacturer
National Council for Prescription Drug Programs
Effective date
2012-07-24
Label type
Indexing - Billing Unit
Version
1
Source
full-release
Hydrated at
2026-06-05 01:20:18

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3001-07ML - Milliliter0781-300123c2caad-ddfe-43ba-aa26-ff69600744eb12012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0781-30010781-3001-07

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021426Omnitropesomatropin351(a)Rx2026-09-01

Source Document#

Source XML

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmnitropeSOMATROPINSandoz Inc58d84ffa-4056-4e36-ad67-7bd4aef444a52025-07-10Warnings, Adverse reactionsExact identifier
ndc (package): 0781-3001-07
ndc11 (package): 00781300107

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.