NDC 0002-8803OTC monographFDA BLA · BLA019717

Humulin 70/30 KwikPen

Active substance: Insulin human

1 formulations • 2 package configurations

All 3 registered NDCs — click to copy

In one line

Humulin 70/30 KwikPen (Insulin human) NDC 0002-8803 converts to 00002-8803-59 for billing and bills under J3590 at Per Administration.

openFDA Live Registry SyncHIPAA 5-4-2 StandardCMS Level II Crosswalk

Listing: 0002-8803

Billing & reimbursement crosswalk

NDC • HCPCS Level II • CPT administration

HCPCS Level II J-Code

J3590

Unclassified biologics (requires invoice & NDC on claim)

Billable unit: Per Administration

11-digit HIPAA NDC

00002-8803-59

Zero-padded 5-4-2 format

Standard conversion

CPT administration code

96401

Chemotherapy / Complex Biologic administration, subcutaneous or intramuscular

UB-04 revenue code

Rev 0636

0636 (Pharmacy - Extension of 0250 Drugs Requiring Detail)

Qualifier: UN

Interactive Unit Multiplier Calculator

J3590

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.

Administered Patient Dose

Units to report on claim:

100 Units

Based on 1 mg = 1 billable unit (100.0 exact)

Box 24 / HCPCS Quantity Formatted Line:J3590 UN100 (N40002880359)

Every registered strength and package for Humulin 70/30 KwikPen, with 10-digit and 11-digit NDC formats
Formulation / role	Package NDC	Product NDC	11-digit HIPAA	Packaging detail	Copy
100 [iU]/mL	0002-8803-59	0002-8803	00002-8803-59	5 SYRINGE in 1 CARTON (0002-8803-59) / 3 mL in 1 SYRINGE (0002-8803-01)
Prefilled syringe	0002-8803-01	0002-8803	00002-8803-01	Inner component of kit (0002-8803-59)

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

Humulin 70/30 KwikPen is indicated for clinical therapeutic management as active pharmaceutical therapy containing INSULIN HUMAN (100 [iU]/mL).

DOSAGE AND ADMINISTRATION

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

DOSAGE FORMS AND STRENGTHS

Supplied as INJECTION, SUSPENSION. Active ingredients: INSULIN HUMAN (100 [iU]/mL).

CONTRAINDICATIONS

Contraindicated in patients with severe hypersensitivity to Insulin human 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: Eli Lilly and Company. Store according to manufacturer packaging specifications at controlled room temperature or refrigerated conditions as marked on commercial carton.