Cromolyn Sodium NDC 57782-397

NDC codes

FDA NDC Directory

Product NDC (as listed)57782-397Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57782-0397Add 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
57782-397-26	57782039726	1 BOTTLE in 1 CARTON (57782-397-26) / 200 SPRAY, METERED in 1 BOTTLEMarketed from Jul 3, 2001

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 — 5.2 mg/1
Dosage form: Spray, Metered
Route: Nasal
Labeler: Bausch & Lomb Incorporated
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075702
Marketing start: Jul 3, 2001
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Histamine Release (Physiologic effect)
Identifiers: Product ID 57782-397_d66445c2-3e1d-458a-9c62-d4fc2ef4ec8fSPL ID d66445c2-3e1d-458a-9c62-d4fc2ef4ec8fSPL set ID 379f4b59-6866-4b5c-9b1b-d8a35b741461RxCUI 1797851UNII 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. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N457782039726 followed by a unit qualifier and the quantity

Package 57782-0397-26. 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 1, 2021.

Indications (excerpt from the label)

Uses to prevent and relieve nasal symptoms of hay fever and other nasal allergies: • runny/itchy nose • sneezing • allergic stuffy nose

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075702

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

FDA NDC Directory listings under ANDA 075702
Product	Strength	Form · route	Labeler	Product NDC
NasalCromcromolyn sodium	Cromolyn sodium 5.2 mg/1	Spray, MeteredNasal	Prestige Brands Holdings, Inc.	52183-199