Prescription drug · ANDA
Clonidine NDC 0378-0871
Clonidine .1 mg/d · Patch · Transdermal · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-0871-99 | 00378087199 | 4 POUCH in 1 CARTON (0378-0871-99) / 1 PATCH in 1 POUCH (0378-0871-16) / 7 d in 1 PATCHMarketed from Feb 25, 2013 |
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)
- Clonidine
- Generic name (nonproprietary)
- clonidine
- Active ingredients
- Clonidine — .1 mg/d
- Dosage form
- Patch
- Route
- Transdermal
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076166
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 0378-0871_40bd0d20-4e93-4e54-b43b-5ba52eb416faSPL ID 40bd0d20-4e93-4e54-b43b-5ba52eb416faSPL set ID 7adfc439-e6d0-4593-87dd-0eef36d33c6dRxCUI 998671, 998675, 998679UNII MN3L5RMN02
- Pharmacologic class
- Central alpha-2 Adrenergic Agonist
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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400378087199followed by a unit qualifier and the quantityPackage 00378-0871-99. 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 Clonidine transdermal system is indicated in the treatment of hypertension. It may be employed alone or concomitantly with other antihypertensive agents.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076166
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.