Prescription drug · BLA

Hyrimoz (adalimumab-adaz) NDC 61314-476

Adalimumab 20 mg/.2mL · Injection, Solution · Subcutaneous · Sandoz Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)61314-476Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61314-0476Add 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
61314-476-64613140476642 SYRINGE, GLASS in 1 CARTON (61314-476-64) / .2 mL in 1 SYRINGE, GLASSMarketed from Jul 1, 2023

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)
Hyrimoz
Generic name (nonproprietary)
adalimumab-adaz
Active ingredients
Adalimumab — 20 mg/.2mL
Dosage form
Injection, Solution
Route
Subcutaneous
Labeler
Sandoz Inc
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 761071
Marketing start
Listing expires
Other FDA classes
Monoclonal (Chemical structure)Tumor Necrosis Factor Receptor Blocking Activity (Mechanism)
Identifiers
Product ID 61314-476_48b7e44a-945f-487d-b2fd-3da13d6d6fdbSPL ID 48b7e44a-945f-487d-b2fd-3da13d6d6fdbSPL set ID 1ac7d061-3380-468c-b077-c05f8dfbc829RxCUI 2641644, 2641650, 2641653, 2641654, 2641655, 2641658, 2641660, 2641661, 2641662, 2641663, 2641664, 2641665, 2641666, 2641667, 2641668, 2641669, 2641670, 2641671, 2641672, 2641673UNII FYS6T7F842

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 codeMed-Code curated

J0135 — Injection, adalimumab, 20 mg

Billing unit: 20 mg. Units on the claim = dose given ÷ 20 mg.

Adalimumab is usually self-administered and dispensed through a pharmacy benefit. Adalimumab biosimilars are listed under their own names.

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

N461314047664 followed by a unit qualifier and the quantity

Package 61314-0476-64. 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

Current FDA label (SPL), effective . This label includes a boxed warning.

Indications (excerpt from the label)

HYRIMOZ is a tumor necrosis factor (TNF)-blocker indicated for: • Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. ( 1.1 ) • Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . (1.3) • Reducing signs and symptoms in adult patients with active ankylosing spondylitis. …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761071

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

FDA NDC Directory listings under BLA 761071
ProductStrengthForm · routeLabelerProduct NDC
Adalimumabadalimumab-adazAdalimumab 80 mg/.8mLInjection, SolutionSubcutaneousSandoz Inc61314-325
Adalimumabadalimumab-adazAdalimumab 40 mg/.4mLInjection, SolutionSubcutaneousSandoz Inc61314-327
Adalimumabadalimumab-adazAdalimumab 20 mg/.2mLInjection, SolutionSubcutaneousSandoz Inc61314-332
Adalimumabadalimumab-adazAdalimumab 10 mg/.1mLInjection, SolutionSubcutaneousSandoz Inc61314-391
Hyrimozadalimumab-adazAdalimumab 10 mg/.1mLInjection, SolutionSubcutaneousSandoz Inc61314-509
Hyrimozadalimumab-adazAdalimumab 80 mg/.8mLInjection, SolutionSubcutaneousSandoz Inc61314-454
Hyrimozadalimumab-adazAdalimumab 40 mg/.4mLInjection, SolutionSubcutaneousSandoz Inc61314-473
Hyrimozadalimumab-adaz—KitSandoz Inc61314-517
Hyrimozadalimumab-adaz—KitSandoz Inc61314-531
Hyrimozadalimumab-adazAdalimumab 40 mg/.8mLInjection, SolutionSubcutaneousCordavis Limited83457-102
Hyrimozadalimumab-adazAdalimumab 40 mg/.4mLInjection, SolutionSubcutaneousCordavis Limited83457-100
Hyrimozadalimumab-adazAdalimumab 40 mg/.4mLInjection, SolutionSubcutaneousCordavis Limited83457-101
Hyrimozadalimumab-adaz—KitCordavis Limited83457-112
Hyrimozadalimumab-adazAdalimumab 40 mg/.8mLInjection, SolutionSubcutaneousCordavis Limited83457-103
Hyrimozadalimumab-adazAdalimumab 80 mg/.8mLInjection, SolutionSubcutaneousCordavis Limited83457-107
Hyrimozadalimumab-adazAdalimumab 20 mg/.2mLInjection, SolutionSubcutaneousCordavis Limited83457-108
Hyrimozadalimumab-adazAdalimumab 80 mg/.8mLInjection, SolutionSubcutaneousCordavis Limited83457-113

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