What is NDC 69616-211?

69616-211 is the product NDC for Firdapse (amifampridine phosphate), Amifampridine phosphate 10 mg/1 tablet, listed with the FDA by Catalyst Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Firdapse (Amifampridine phosphate).

Catalyst Pharmaceuticals, Inc., NDC labeler code 69616. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Firdapse?

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.

Firdapse NDC 69616-211 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69616-211Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69616-0211Add 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
69616-211-03	69616021103	240 TABLET in 1 BOTTLE, PLASTIC (69616-211-03)Marketed from Jan 7, 2019
69616-211-06	69616021106	12 BLISTER PACK in 1 CARTON (69616-211-06) / 10 TABLET in 1 BLISTER PACK (69616-211-04)Marketed from Jan 7, 2019
69616-211-08	69616021108	60 TABLET in 1 BOTTLE, PLASTIC (69616-211-08)Marketed from Jan 7, 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): Firdapse
Generic name (nonproprietary): amifampridine phosphate
Active ingredients: Amifampridine phosphate — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Catalyst Pharmaceuticals, Inc.NDC labeler code 69616
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208078
Marketing start: Jan 7, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Potassium Channel Antagonists (Mechanism)
Identifiers: Product ID 69616-211_4f94edd2-b6a8-264d-e063-6294a90a89dfSPL ID 4f94edd2-b6a8-264d-e063-6294a90a89dfSPL set ID f015fe60-3128-4a43-8c31-19fc6b5def3fRxCUI 2106343, 2107518UNII 8HF8FIN815
Pharmacologic class: Potassium Channel Blocker

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N469616021103 followed by a unit qualifier and the quantity

Package 69616-0211-03. 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 Apr 16, 2026.

Indications (excerpt from the label)

FIRDAPSE ® is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older. FIRDAPSE is a potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69616-211

What is NDC 69616-211?: 69616-211 is the product NDC for Firdapse (amifampridine phosphate), Amifampridine phosphate 10 mg/1 tablet, listed with the FDA by Catalyst Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Firdapse (Amifampridine phosphate).
What is the active ingredient?: Amifampridine phosphate.
Who is the labeler?: Catalyst Pharmaceuticals, Inc., NDC labeler code 69616. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Firdapse?: 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.

Firdapse (Amifampridine phosphate) NDC 69616-211