What is NDC 71904-200?

71904-200 is the product NDC for Pombiliti Atga (cipaglucosidase alfa-atga), Cipaglucosidase alfa 105 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by AMICUS THERAPEUTICS US, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Pombiliti Atga (Cipaglucosidase alfa-atga).

AMICUS THERAPEUTICS US, LLC, NDC labeler code 71904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Pombiliti Atga?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pombiliti Atga NDC 71904-200 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71904-200Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71904-0200Add 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 NDC	11-digit (billing)	Package
71904-200-01	71904020001	1 VIAL, GLASS in 1 CARTON (71904-200-01) / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASSMarketed from Oct 11, 2023
71904-200-02	71904020002	10 VIAL, GLASS in 1 CARTON (71904-200-02) / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASSMarketed from Oct 11, 2023
71904-200-03	71904020003	25 VIAL, GLASS in 1 CARTON (71904-200-03) / 105 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASSMarketed from Oct 11, 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): Pombiliti AtgaSuffix: ATGA
Generic name (nonproprietary): cipaglucosidase alfa-atga
Active ingredients: Cipaglucosidase alfa — 105 mg/1
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: AMICUS THERAPEUTICS US, LLCNDC labeler code 71904
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 761204
Marketing start: Oct 11, 2023
Listing expires: Dec 31, 2027
Other FDA classes: alpha-Glucosidases (Chemical structure)
Identifiers: Product ID 71904-200_5d85b45c-1ab9-41f2-b917-2e62606fb132SPL ID 5d85b45c-1ab9-41f2-b917-2e62606fb132SPL set ID d77aa596-910d-516b-e053-2995a90a0839RxCUI 2667440, 2667446UNII 4SED7F4BSGUPC 0371904200033, 0371904200019
Pharmacologic class: Hydrolytic Lysosomal Glycogen-specific Enzyme

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

N471904020001 followed by a unit qualifier and the quantity

Package 71904-0200-01. 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

Current FDA label (SPL), effective Aug 12, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

POMBILITI is indicated, in combination with Opfolda, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT). POMBILITI is a hydrolytic lysosomal glycogen-specific enzyme indicated, in combination with Opfolda, an enzyme stabilizer, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT). ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71904-200

What is NDC 71904-200?: 71904-200 is the product NDC for Pombiliti Atga (cipaglucosidase alfa-atga), Cipaglucosidase alfa 105 mg/1 injection, powder, lyophilized, for solution, listed with the FDA by AMICUS THERAPEUTICS US, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Pombiliti Atga (Cipaglucosidase alfa-atga).
What is the active ingredient?: Cipaglucosidase alfa.
Who is the labeler?: AMICUS THERAPEUTICS US, LLC, NDC labeler code 71904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pombiliti Atga?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Pombiliti Atga (Cipaglucosidase alfa-atga) NDC 71904-200