Prescription drug · ANDA
Cromolyn Sodium NDC 42571-132
Cromolyn sodium 100 mg/5mL · Solution, Concentrate · Oral · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-132-52 | 42571013252 | 96 CARTON in 1 CARTON (42571-132-52) / 1 TRAY in 1 CARTON / 8 AMPULE in 1 TRAY / 5 mL in 1 AMPULE (42571-132-21)Marketed from May 4, 2013 |
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
- Micro Labs Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202745
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Histamine Release (Physiologic effect)
- Identifiers
- Product ID 42571-132_22ffea9c-cd39-22dd-e063-6394a90aae4bSPL ID 22ffea9c-cd39-22dd-e063-6394a90aae4bSPL set ID 93f80edb-3b38-423e-8cd6-5b5cb4393ec2RxCUI 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
N442571013252followed by a unit qualifier and the quantityPackage 42571-0132-52. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 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.