Gastrocrom (cromolyn sodium) NDC 0037-0678

NDC codes

FDA NDC Directory

Product NDC (as listed)0037-0678Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00037-0678Add 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
0037-0678-96	00037067896	12 POUCH in 1 CARTON (0037-0678-96) / 8 AMPULE in 1 POUCH (0037-0678-08) / 5 mL in 1 AMPULEMarketed from May 1, 2015

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): Gastrocrom
Generic name (nonproprietary): cromolyn sodium
Active ingredients: Cromolyn sodium — 20 mg/mL
Dosage form: Liquid
Route: Oral
Labeler: Viatris Specialty LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020479
Marketing start: May 1, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Histamine Release (Physiologic effect)
Identifiers: Product ID 0037-0678_15aec235-80e7-4d95-b48c-bbca69b4b04dSPL ID 15aec235-80e7-4d95-b48c-bbca69b4b04dSPL set ID 00623958-a8fe-47d1-a0d2-0aa4e2f7966eRxCUI 831261, 831269UNII 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

N400037067896 followed by a unit qualifier and the quantity

Package 00037-0678-96. 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 Jun 26, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE GASTROCROM 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)