What is NDC 61314-237?

61314-237 is the product NDC for Cromolyn Sodium, Cromolyn sodium 40 mg/mL solution/ drops, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 61314. 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 61314-237 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61314-237Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61314-0237Add 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
61314-237-10	6131402371061314023710	1 BOTTLE, PLASTIC in 1 CARTON (61314-237-10) / 10 mL in 1 BOTTLE, PLASTICMarketed from Jun 29, 1999

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 — 40 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Sandoz IncNDC labeler code 61314
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075282
Marketing start: Jun 29, 1999
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Histamine Release (Physiologic effect)
Identifiers: Product ID 61314-237_bfef6d6b-b5e5-4f8c-89c5-718e2c65cc6aSPL ID bfef6d6b-b5e5-4f8c-89c5-718e2c65cc6aSPL set ID b32851c3-cd97-4be4-a09c-1deab1d6966bRxCUI 831109UNII Q2WXR1I0PKUPC 0361314237101
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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N461314023710 followed by a unit qualifier and the quantity

Package 61314-0237-10. 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 Feb 20, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Cromolyn Sodium Ophthalmic Solution USP, 4% is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61314-237

What is NDC 61314-237?: 61314-237 is the product NDC for Cromolyn Sodium, Cromolyn sodium 40 mg/mL solution/ drops, listed with the FDA by Sandoz Inc. 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?: Sandoz Inc, NDC labeler code 61314. 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 100 mg/5mL	Solution, ConcentrateOral	Omnivium Pharmaceuticals LLC	81665-104	81665-0104-96
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	Proficient Rx LP	71205-230	71205-0230-10

Other NDCs under ANDA 075282

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

FDA NDC Directory listings under ANDA 075282
Product	Strength	Form · route	Labeler	Product NDC
Cromolyn Sodium	Cromolyn sodium 40 mg/mL	Solution/ dropsOphthalmic	A-S Medication Solutions	50090-1202
Cromolyn Sodium	Cromolyn sodium 40 mg/mL	Solution/ dropsOphthalmic	Preferred Pharmaceuticals Inc.	68788-8490
Cromolyn Sodium	Cromolyn sodium 40 mg/mL	Solution/ dropsOphthalmic	Proficient Rx LP	71205-230