NDC codes

FDA NDC Directory
Product NDC (as listed)0002-3115Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00002-3115Add 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
0002-3115-09000023115093 SYRINGE in 1 CARTON (0002-3115-09) / 1 mL in 1 SYRINGE (0002-3115-01)Marketed from Jun 17, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Emgality
Generic name (nonproprietary)
galcanezumab-gnlm
Active ingredients
Galcanezumab100 mg/mL
Dosage form
Injection, Solution
Route
Subcutaneous
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 761063
Marketing start
Listing expires
Identifiers
Product ID 0002-3115_b58a1b24-8a42-4073-9413-4f9b7c308a64SPL ID b58a1b24-8a42-4073-9413-4f9b7c308a64SPL set ID 33a147be-233a-40e8-a55e-e40936e28db0RxCUI 2058872, 2058877, 2058885, 2058887, 2170611, 2170613UNII 55KHL3P693

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

N400002311509 followed by a unit qualifier and the quantity

Package 00002-3115-09. 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 .

Indications (excerpt from the label)

EMGALITY ® is a calcitonin-gene related peptide antagonist indicated in adults for the: preventive treatment of migraine. ( 1.1 ) treatment of episodic cluster headache. ( 1.2 ) 1.1 Migraine EMGALITY is indicated for the preventive treatment of migraine in adults. 1.2 Episodic Cluster Headache EMGALITY is indicated for the treatment of episodic cluster headache in adults.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761063

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

FDA NDC Directory listings under BLA 761063
ProductStrengthForm · routeLabelerProduct NDC
Emgalitygalcanezumab-gnlmGalcanezumab 120 mg/mLInjection, SolutionSubcutaneousEli Lilly and Company0002-2377
Emgalitygalcanezumab-gnlmGalcanezumab 120 mg/mLInjection, SolutionSubcutaneousEli Lilly and Company0002-1436

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