Prescription drug · ANDA
Clonidine transdermal system (Clonidine) NDC 0591-3510
Clonidine .3 mg/d · Patch · Transdermal · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-3510-04 | 0059135100400591351004 | 4 POUCH in 1 CARTON (0591-3510-04) / 1 PATCH in 1 POUCH (0591-3510-54) / 7 d in 1 PATCHMarketed from May 6, 2014 |
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 transdermal system
- Generic name (nonproprietary)
- clonidine
- Active ingredients
- Clonidine — .3 mg/d
- Dosage form
- Patch
- Route
- Transdermal
- Labeler
- Actavis Pharma, Inc.NDC labeler code 0591
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090873
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 0591-3510_996f475b-4f8b-4487-b5c1-6e5c4f284045SPL ID 996f475b-4f8b-4487-b5c1-6e5c4f284045SPL set ID 99a59495-2a48-4276-bbe3-cdd55a45aba4RxCUI 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
N400591351004followed by a unit qualifier and the quantityPackage 00591-3510-04. 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.
About NDC 0591-3510
- What is NDC 0591-3510?
- 0591-3510 is the product NDC for Clonidine transdermal system (clonidine), Clonidine .3 mg/d patch, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clonidine transdermal system (Clonidine).
- What is the active ingredient?
- Clonidine.
- Who is the labeler?
- Actavis Pharma, Inc., NDC labeler code 0591. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Clonidine transdermal system?
- 2 other product NDCs are listed under this name. See all Clonidine transdermal system NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clonidine transdermal system products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Clonidine transdermal systemclonidine | Clonidine .1 mg/d | PatchTransdermal | Actavis Pharma, Inc. | 0591-3508 | 00591-3508-04 |
| Clonidine transdermal systemclonidine | Clonidine .2 mg/d | PatchTransdermal | Actavis Pharma, Inc. | 0591-3509 | 00591-3509-04 |
Other NDCs under ANDA 090873
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 |
|---|---|---|---|---|
| Clonidine transdermal systemclonidine | Clonidine .1 mg/d | PatchTransdermal | Actavis Pharma, Inc. | 0591-3508 |
| Clonidine transdermal systemclonidine | Clonidine .2 mg/d | PatchTransdermal | Actavis Pharma, Inc. | 0591-3509 |