NDC codes

FDA NDC Directory
Product NDC (as listed)68982-810Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68982-0810Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
68982-810-01689820810011 VIAL, GLASS in 1 CARTON (68982-810-01) / 6 mL in 1 VIAL, GLASS (68982-810-81)Marketed from May 3, 2019
68982-810-02689820810021 VIAL, GLASS in 1 CARTON (68982-810-02) / 10 mL in 1 VIAL, GLASS (68982-810-82)Marketed from May 3, 2019
68982-810-03689820810031 VIAL, GLASS in 1 CARTON (68982-810-03) / 12 mL in 1 VIAL, GLASS (68982-810-83)Marketed from May 3, 2019
68982-810-04689820810041 VIAL, GLASS in 1 CARTON (68982-810-04) / 20 mL in 1 VIAL, GLASS (68982-810-84)Marketed from May 3, 2019
68982-810-05689820810051 VIAL, GLASS in 1 CARTON (68982-810-05) / 24 mL in 1 VIAL, GLASS (68982-810-85)Marketed from May 3, 2019
68982-810-06689820810061 VIAL, GLASS in 1 CARTON (68982-810-06) / 48 mL in 1 VIAL, GLASS (68982-810-86)Marketed from May 3, 2019

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Cutaquig
Generic name (nonproprietary)
immunoglobulin g
Active ingredients
Human immunoglobulin g — 165 mg/mL
Dosage form
Solution
Route
Subcutaneous
Product type
Plasma derivative
Marketing category
BLA — Biologics License ApplicationApplication BLA 125668
Marketing start
Listing expires
Other FDA classes
Antigen Neutralization (Mechanism)Immunoglobulins (Chemical structure)Passively Acquired Immunity (Physiologic effect)
Identifiers
Product ID 68982-810_92279fbb-b633-80a9-0e99-5883db7ca60bSPL ID 92279fbb-b633-80a9-0e99-5883db7ca60b
Pharmacologic class
Human Immunoglobulin G

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N468982081001 followed by a unit qualifier and the quantity

Package 68982-0810-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under BLA 125668

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 125668
ProductStrengthForm · routeLabelerProduct NDC
Cutaquigimmunoglobulin gHuman immunoglobulin g 165 mg/mLSolutionSubcutaneousPfizer Laboratories Div Pfizer Inc0069-1965
Cutaquigimmunoglobulin gHuman immunoglobulin g 165 mg/mLSolutionSubcutaneousPfizer Laboratories Div Pfizer Inc0069-1476
Cutaquigimmunoglobulin gHuman immunoglobulin g 165 mg/mLSolutionSubcutaneousPfizer Laboratories Div Pfizer Inc0069-1802
Cutaquigimmunoglobulin gHuman immunoglobulin g 165 mg/mLSolutionSubcutaneousPfizer Laboratories Div Pfizer Inc0069-1960
Cutaquigimmunoglobulin gHuman immunoglobulin g 165 mg/mLSolutionSubcutaneousPfizer Laboratories Div Pfizer Inc0069-1509
Cutaquigimmunoglobulin gHuman immunoglobulin g 165 mg/mLSolutionSubcutaneousPfizer Laboratories Div Pfizer Inc0069-1061

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