NDC 0169-7010OTC monographFDA BLA · BLA103665

NovoSeven RT

Active substance: Coagulation Factor VIIa (Recombinant)

8 formulations • 24 package configurations

All 32 registered NDCs — click to copy

In one line

NovoSeven RT (Coagulation Factor VIIa (Recombinant)) NDC 0169-7010 converts to 00169-7010-01 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: 0169-7010

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

00169-7010-01

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

Every registered strength and package for NovoSeven RT, with 10-digit and 11-digit NDC formats
Formulation / role	Package NDC	Product NDC	11-digit HIPAA	Packaging detail
Outer kit carton	0169-7010-01	0169-7010	00169-7010-01	1 KIT in 1 KIT (0169-7010-01) * 1 mL in 1 VIAL, GLASS (0169-7017-11) * 1 mL in 1 VIAL, GLASS (0169-7001-98)
Vial component	0169-7017-11	0169-7010	00169-7017-11	Inner component of kit (0169-7010-01)
Vial component	0169-7001-98	0169-7010	00169-7001-98	Inner component of kit (0169-7010-01)
Outer kit carton	0169-7020-01	0169-7020	00169-7020-01	1 KIT in 1 KIT (0169-7020-01) * 2 mL in 1 VIAL, GLASS (0169-7027-11) * 2 mL in 1 VIAL, GLASS (0169-7002-98)
Vial component	0169-7027-11	0169-7020	00169-7027-11	Inner component of kit (0169-7020-01)
Vial component	0169-7002-98	0169-7020	00169-7002-98	Inner component of kit (0169-7020-01)
Outer kit carton	0169-7040-01	0169-7040	00169-7040-01	1 KIT in 1 KIT (0169-7040-01) * 8 mL in 1 VIAL, GLASS (0169-7047-11) * 8 mL in 1 VIAL, GLASS (0169-7004-98)
Vial component	0169-7047-11	0169-7040	00169-7047-11	Inner component of kit (0169-7040-01)
Vial component	0169-7004-98	0169-7040	00169-7004-98	Inner component of kit (0169-7040-01)
Outer kit carton	0169-7050-01	0169-7050	00169-7050-01	1 KIT in 1 KIT (0169-7050-01) * 5 mL in 1 VIAL, GLASS (0169-7057-11) * 5 mL in 1 VIAL, GLASS (0169-7005-98)
Vial component	0169-7057-11	0169-7050	00169-7057-11	Inner component of kit (0169-7050-01)
Vial component	0169-7005-98	0169-7050	00169-7005-98	Inner component of kit (0169-7050-01)
Outer kit carton	0169-7201-01	0169-7201	00169-7201-01	1 KIT in 1 KIT (0169-7201-01) * 1 mL in 1 VIAL, GLASS (0169-7211-11) * 1 mL in 1 SYRINGE, GLASS (0169-7011-98)
Vial component	0169-7211-11	0169-7201	00169-7211-11	Inner component of kit (0169-7201-01)
Vial component	0169-7011-98	0169-7201	00169-7011-98	Inner component of kit (0169-7201-01)
Outer kit carton	0169-7202-01	0169-7202	00169-7202-01	1 KIT in 1 KIT (0169-7202-01) * 2 mL in 1 VIAL, GLASS (0169-7212-11) * 2 mL in 1 SYRINGE, GLASS (0169-7012-98)
Vial component	0169-7212-11	0169-7202	00169-7212-11	Inner component of kit (0169-7202-01)
Vial component	0169-7012-98	0169-7202	00169-7012-98	Inner component of kit (0169-7202-01)
Outer kit carton	0169-7205-01	0169-7205	00169-7205-01	1 KIT in 1 KIT (0169-7205-01) * 5 mL in 1 VIAL, GLASS (0169-7215-11) * 5 mL in 1 SYRINGE, GLASS (0169-7015-98)
Vial component	0169-7215-11	0169-7205	00169-7215-11	Inner component of kit (0169-7205-01)
Vial component	0169-7015-98	0169-7205	00169-7015-98	Inner component of kit (0169-7205-01)
Outer kit carton	0169-7208-01	0169-7208	00169-7208-01	1 KIT in 1 KIT (0169-7208-01) * 8 mL in 1 SYRINGE, GLASS (0169-7018-98) * 8 mL in 1 VIAL, GLASS (0169-7218-11)
Vial component	0169-7018-98	0169-7208	00169-7018-98	Inner component of kit (0169-7208-01)
Vial component	0169-7218-11	0169-7208	00169-7218-11	Inner component of kit (0169-7208-01)

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

INDICATIONS AND USAGE

NovoSeven RT is indicated for clinical therapeutic management as active pharmaceutical therapy containing Coagulation Factor VIIa (Recombinant).

DOSAGE AND ADMINISTRATION

Dosage must be individualized based on clinical therapeutic goals, route of administration (Standard Administration), and patient response. Refer to licensed physician prescribing guidelines.

DOSAGE FORMS AND STRENGTHS

Supplied as KIT. Active ingredients: Coagulation Factor VIIa (Recombinant).

CONTRAINDICATIONS

Contraindicated in patients with severe hypersensitivity to Coagulation Factor VIIa (Recombinant) or formulation components.

WARNINGS AND PRECAUTIONS

Review complete patient medical history, potential contraindications, and drug-drug interactions prior to initiation.

HOW SUPPLIED / STORAGE AND HANDLING

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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Terms used here11-digit NDC Package NDC N4 qualifier

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NDC • HCPCS Level II • CPT administration

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Novo Nordisk A/S