Prescription drug · ANDA
Cromolyn Sodium NDC 71205-230
Cromolyn sodium 40 mg/mL · Solution/ drops · Ophthalmic · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-230-10 | 71205023010 | 10 mL in 1 BOTTLE, PLASTIC (71205-230-10)Marketed from Mar 1, 2019 |
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
- Proficient Rx LP
- 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 71205-230_1c80e622-005d-44f1-a5a9-2e0acd59e485SPL ID 1c80e622-005d-44f1-a5a9-2e0acd59e485SPL set ID 34ef00e8-0c01-4225-9a40-822ab245752aRxCUI 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
N471205023010followed by a unit qualifier and the quantityPackage 71205-0230-10. 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 .
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 | A-S Medication Solutions | 50090-1202 |