NDC 0169-8100OTC monographFDA BLA · BLA125671

Esperoct

Active substance: Antihemophilic factor (recombinant), glycopegylated-exei

FDA labeler: Novo Nordisk

7 formulations • 21 package configurations
All 28 registered NDCs — click to copy
In one line

Esperoct (Antihemophilic factor (recombinant), glycopegylated-exei) NDC 0169-8100 converts to 00169-8100-01 for billing. It is dispensed by a pharmacy and billed directly on the NDC — no HCPCS J-code is required.

openFDA Live Registry SyncHIPAA 5-4-2 StandardCMS Level II Crosswalk
Listing: 0169-8100
Billing & reimbursement crosswalk

NDC • HCPCS Level II • CPT administration

Reimbursement channel
NDC direct
Oral / Topical formulation billed directly via 11-Digit NDC (No HCPCS J-Code required).
Standard pharmacy claim — no J-Code required
11-digit HIPAA NDC
00169-8100-01
Zero-padded 5-4-2 format
Standard conversion
CPT administration code
Self-Administered (Oral)
Dispensed via retail/mail pharmacy. No clinical administration procedure (CPT) required.
UB-04 revenue code
Rev 0250
0250 (General Pharmacy)
Qualifier: UN
Complete drug registry

All registered strengths & packaging

Every registered strength and package for ESPEROCT, with 10-digit and 11-digit NDC formats
Formulation / rolePackage NDCProduct NDC11-digit HIPAAPackaging detailCopy
Outer kit carton0169-8055-010169-805500169-8055-011 KIT in 1 KIT (0169-8055-01) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) * 4 mL in 1 VIAL, GLASS (0169-8051-11)
Vial component0169-8008-980169-805500169-8008-98Inner component of kit (0169-8055-01)
Vial component0169-8051-110169-805500169-8051-11Inner component of kit (0169-8055-01)
Outer kit carton0169-8100-010169-810000169-8100-011 KIT in 1 KIT (0169-8100-01) * 4 mL in 1 VIAL, GLASS (0169-8101-90) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) * 4 mL in 1 VIAL, GLASS (0169-8101-11)
Vial component0169-8101-900169-810000169-8101-90Inner component of kit (0169-8100-01)
Vial component0169-8101-110169-810000169-8101-11Inner component of kit (0169-8100-01)
Outer kit carton0169-8100-930169-810000169-8100-931 KIT in 1 KIT (0169-8100-93) * 4 mL in 1 VIAL, GLASS (0169-8101-90) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) * 4 mL in 1 VIAL, GLASS (0169-8101-11)
Outer kit carton0169-8150-010169-815000169-8150-011 KIT in 1 KIT (0169-8150-01) * 4 mL in 1 VIAL, GLASS (0169-8151-11) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98)
Vial component0169-8151-110169-815000169-8151-11Inner component of kit (0169-8150-01)
Outer kit carton0169-8200-010169-820000169-8200-011 KIT in 1 KIT (0169-8200-01) * 4 mL in 1 VIAL, GLASS (0169-8201-11) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98)
Vial component0169-8201-110169-820000169-8201-11Inner component of kit (0169-8200-01)
Outer kit carton0169-8300-010169-830000169-8300-011 KIT in 1 KIT (0169-8300-01) * 4 mL in 1 VIAL, GLASS (0169-8301-90) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) * 4 mL in 1 VIAL, GLASS (0169-8301-11)
Vial component0169-8301-900169-830000169-8301-90Inner component of kit (0169-8300-01)
Vial component0169-8301-110169-830000169-8301-11Inner component of kit (0169-8300-01)
Outer kit carton0169-8300-930169-830000169-8300-931 KIT in 1 KIT (0169-8300-93) * 4 mL in 1 VIAL, GLASS (0169-8301-90) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) * 4 mL in 1 VIAL, GLASS (0169-8301-11)
Outer kit carton0169-8400-010169-840000169-8400-011 KIT in 1 KIT (0169-8400-01) * 4 mL in 1 VIAL, GLASS (0169-8401-11) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98)
Vial component0169-8401-110169-840000169-8401-11Inner component of kit (0169-8400-01)
Outer kit carton0169-8500-010169-850000169-8500-011 KIT in 1 KIT (0169-8500-01) * 4 mL in 1 VIAL, GLASS (0169-8501-90) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) * 4 mL in 1 VIAL, GLASS (0169-8501-11)
Vial component0169-8501-900169-850000169-8501-90Inner component of kit (0169-8500-01)
Vial component0169-8501-110169-850000169-8501-11Inner component of kit (0169-8500-01)
Outer kit carton0169-8500-930169-850000169-8500-931 KIT in 1 KIT (0169-8500-93) * 4 mL in 1 VIAL, GLASS (0169-8501-90) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) * 4 mL in 1 VIAL, GLASS (0169-8501-11)
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
ESPEROCT is indicated for clinical therapeutic management as active pharmaceutical therapy containing antihemophilic factor (recombinant), glycopegylated-exei.
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: antihemophilic factor (recombinant), glycopegylated-exei.
Contraindicated in patients with severe hypersensitivity to antihemophilic factor (recombinant), glycopegylated-exei or formulation components.
Review complete patient medical history, potential contraindications, and drug-drug interactions prior to initiation.
Supplied under FDA Labeler: Novo Nordisk. Store according to manufacturer packaging specifications at controlled room temperature or refrigerated conditions as marked on commercial carton.
Labeler

Novo Nordisk A/S

Full NDC portfolio, brand list and J-code coverage for this manufacturer.

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