What is NDC 81665-104?

81665-104 is the product NDC for Cromolyn Sodium, Cromolyn sodium 100 mg/5mL solution, concentrate, listed with the FDA by Omnivium Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Omnivium Pharmaceuticals LLC, NDC labeler code 81665. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Cromolyn Sodium?

8 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Cromolyn Sodium NDC 81665-104 | National Drug Code

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	8166501049681665010496	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 LLCNDC labeler code 81665
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)

About NDC 81665-104

What is NDC 81665-104?: 81665-104 is the product NDC for Cromolyn Sodium, Cromolyn sodium 100 mg/5mL solution, concentrate, listed with the FDA by Omnivium Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Cromolyn Sodium.
What is the active ingredient?: Cromolyn sodium.
Who is the labeler?: Omnivium Pharmaceuticals LLC, NDC labeler code 81665. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cromolyn Sodium?: 8 other product NDCs are listed under this name. See all Cromolyn Sodium NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Cromolyn Sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Cromolyn Sodium	Cromolyn sodium 40 mg/mL	Solution/ dropsOphthalmic	Preferred Pharmaceuticals Inc.	68788-8490	68788-8490-01
Cromolyn Sodium	Cromolyn sodium 100 mg/5mL	Solution, ConcentrateOral	Micro Labs Limited	42571-132	42571-0132-52
Cromolyn Sodium	Cromolyn sodium 100 mg/5mL	Solution, ConcentrateOral	Rising Pharma Holdings, Inc.	16571-600	16571-0600-96
Cromolyn Sodium	Cromolyn sodium 5.2 mg/1	Spray, MeteredNasal	Bausch & Lomb Incorporated	57782-397	57782-0397-26
Cromolyn Sodium	Cromolyn sodium 20 mg/2mL	SolutionIntrabronchial	Teva Pharmaceuticals USA, Inc.	0172-6406	00172-6406-49
Cromolyn Sodium	Cromolyn sodium 40 mg/mL	Solution/ dropsOphthalmic	A-S Medication Solutions	50090-1202	50090-1202-00
Cromolyn Sodium	Cromolyn sodium 40 mg/mL	Solution/ dropsOphthalmic	Sandoz Inc	61314-237	61314-0237-10
Cromolyn Sodium	Cromolyn sodium 40 mg/mL	Solution/ dropsOphthalmic	Proficient Rx LP	71205-230	71205-0230-10