What is NDC 16571-600?

16571-600 is the product NDC for Cromolyn Sodium, Cromolyn sodium 100 mg/5mL solution, concentrate, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Rising Pharma Holdings, Inc., NDC labeler code 16571. 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 16571-600 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-600Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0600Add 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
16571-600-96	1657106009616571060096	12 POUCH in 1 CARTON (16571-600-96) / 8 AMPULE in 1 POUCH / 5 mL in 1 AMPULEMarketed from Dec 5, 2011

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: Rising Pharma Holdings, Inc.NDC labeler code 16571
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202583
Marketing start: Dec 5, 2011
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Histamine Release (Physiologic effect)
Identifiers: Product ID 16571-600_ca2c72ae-db00-4694-9fd0-d4b6b45f8108SPL ID ca2c72ae-db00-4694-9fd0-d4b6b45f8108SPL set ID 61c9cb85-129e-4490-b5f7-357307fcecbfRxCUI 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

N416571060096 followed by a unit qualifier and the quantity

Package 16571-0600-96. 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 Aug 1, 2021.

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 16571-600

What is NDC 16571-600?: 16571-600 is the product NDC for Cromolyn Sodium, Cromolyn sodium 100 mg/5mL solution, concentrate, listed with the FDA by Rising Pharma Holdings, 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?: Rising Pharma Holdings, Inc., NDC labeler code 16571. 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 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