Prescription drug · ANDA
Cromolyn Sodium NDC 50090-1202
Cromolyn sodium 40 mg/mL · Solution/ drops · Ophthalmic · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-1202-0 | 50090120200 | 10 mL in 1 BOTTLE, PLASTIC (50090-1202-0)Marketed from Nov 28, 2014 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075282
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Histamine Release (Physiologic effect)
- Identifiers
- Product ID 50090-1202_b616081b-35e0-4507-aaa1-1f2d7cc80fa7SPL ID b616081b-35e0-4507-aaa1-1f2d7cc80fa7SPL set ID 0d30fb0a-e343-426d-8203-5816bd4cec2fRxCUI 831109UNII 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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450090120200followed by a unit qualifier and the quantityPackage 50090-1202-00. 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 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.
Other NDCs under ANDA 075282
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cromolyn Sodium | Cromolyn sodium 40 mg/mL | Solution/ dropsOphthalmic | Sandoz Inc | 61314-237 |
| 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 |