Cromolyn Sodium NDC 81665-104

NDC codes

FDA NDC Directory

Product NDC (as listed)81665-104Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81665-0104Add 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	Copy
81665-104-96	81665010496	12 POUCH in 1 CARTON (81665-104-96) / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULEMarketed from Aug 31, 2024

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): Cromolyn Sodium
Generic name (nonproprietary): cromolyn sodium
Active ingredients: Cromolyn sodium — 100 mg/5mL
Dosage form: Solution, Concentrate
Route: Oral
Labeler: Omnivium Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209264
Marketing start: Aug 31, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Histamine Release (Physiologic effect)
Identifiers: Product ID 81665-104_fd09b0f1-907c-4d4d-a693-9756efd60f20SPL ID fd09b0f1-907c-4d4d-a693-9756efd60f20SPL set ID a742664b-265e-49f9-9744-d04e1fb620aeRxCUI 831261UNII Q2WXR1I0PK
Pharmacologic class: Mast Cell Stabilizer

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

N481665010496 followed by a unit qualifier and the quantity

Package 81665-0104-96. 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 Jan 13, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Cromolyn Sodium Oral Solution (Concentrate) is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)