Prescription drug · NDA
Cystagon (Cysteamine bitartrate) NDC 0378-9045
Cysteamine bitartrate 150 mg/1 · Capsule · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-9045-05 | 00378904505 | 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9045-05)Marketed from Apr 11, 2005 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Cystagon
- Generic name (nonproprietary)
- cysteamine bitartrate
- Active ingredients
- Cysteamine bitartrate — 150 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.NDC labeler code 0378
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020392
- Marketing start
- Listing expires
- Other FDA classes
- Cystine Disulfide Reduction (Mechanism)
- Identifiers
- Product ID 0378-9045_29dfd298-96ed-4a5f-a573-b24f5ffa618bSPL ID 29dfd298-96ed-4a5f-a573-b24f5ffa618bSPL set ID f495b76d-96c6-48e5-8fa3-30a4336628ebRxCUI 209788, 209789, 309636, 309637UNII QO84GZ3TSTUPC 0303789045058, 0303789040053
- Pharmacologic class
- Cystine Depleting Agent
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
N400378904505followed by a unit qualifier and the quantityPackage 00378-9045-05. 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 CYSTAGON ® is indicated for the management of nephropathic cystinosis in children and adults.
Excerpt only. Read the full label for complete information.
About NDC 0378-9045
- What is NDC 0378-9045?
- 0378-9045 is the product NDC for Cystagon (cysteamine bitartrate), Cysteamine bitartrate 150 mg/1 capsule, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cystagon (Cysteamine bitartrate).
- What is the active ingredient?
- Cysteamine bitartrate.
- Who is the labeler?
- Mylan Pharmaceuticals Inc., NDC labeler code 0378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cystagon?
- 1 other product NDC are listed under this name. See all Cystagon NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cystagon products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cystagoncysteamine bitartrate | Cysteamine bitartrate 50 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-9040 | 00378-9040-05 |
Other NDCs under NDA 020392
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 |
|---|---|---|---|---|
| Cystagoncysteamine bitartrate | Cysteamine bitartrate 50 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-9040 |