Prescription drug · ANDA
Clonidine NDC 50742-247
Clonidine hydrochloride .1 mg/1 · Tablet, Extended release · Oral · Ingenus Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50742-247-05 | 5074202470550742024705 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-247-05)Marketed from Mar 5, 2019 | |
| 50742-247-30 | 5074202473050742024730 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-247-30)Marketed from Mar 5, 2019 | |
| 50742-247-60 | 5074202476050742024760 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-247-60)Marketed from Mar 5, 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)
- Clonidine
- Generic name (nonproprietary)
- clonidine
- Active ingredients
- Clonidine hydrochloride — .1 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Ingenus Pharmaceuticals, LLCNDC labeler code 50742
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209675
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 50742-247_4f2ad773-518b-4532-bb69-8ff28c4f24c4SPL ID 4f2ad773-518b-4532-bb69-8ff28c4f24c4SPL set ID 99485427-a120-4fc7-bb61-25857d1900ecRxCUI 1013930UNII W76I6XXF06UPC 0350742247608
- 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450742024705followed by a unit qualifier and the quantityPackage 50742-0247-05. 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)
Clonidine hydrochloride extended-release tablets is a centrally acting alpha 2 -adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications. ( 1 ) Clonidine hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications [see Clinical Studies ( 14 )].
Excerpt only. Read the full label for complete information.
About NDC 50742-247
- What is NDC 50742-247?
- 50742-247 is the product NDC for Clonidine, Clonidine hydrochloride .1 mg/1 tablet, extended release, listed with the FDA by Ingenus Pharmaceuticals, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Clonidine.
- What is the active ingredient?
- Clonidine hydrochloride.
- Who is the labeler?
- Ingenus Pharmaceuticals, LLC, NDC labeler code 50742. 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?
- 11 other product NDCs are listed under this name. See all Clonidine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Clonidine 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 | Clonidine .1 mg/24h | Patch, Extended releaseTransdermal | Dr. Reddy's Labratories Inc. | 75907-023 | 75907-0023-48 |
| Clonidine | Clonidine .2 mg/24h | Patch, Extended releaseTransdermal | Dr. Reddy's Labratories Inc. | 75907-024 | 75907-0024-48 |
| Clonidine | Clonidine .3 mg/24h | Patch, Extended releaseTransdermal | Dr. Reddy's Labratories Inc. | 75907-025 | 75907-0025-48 |
| Clonidine | Clonidine .17 mg/1 | Tablet, Extended releaseOral | TruPharma, LLC | 52817-375 | 52817-0375-30 |
| Clonidine | Clonidine .17 mg/1 | Tablet, Extended releaseOral | PALMETTO PHARMACEUTICALS INC. | 68134-603 | 68134-0603-30 |
| Clonidine | Clonidine .3 mg/24h | Patch, Extended releaseTransdermal | Mayne Pharma Inc. | 51862-455 | — |
| Clonidine | Clonidine hydrochloride 100 ug/mL | Injection, SolutionEpidural | XGen Pharmaceuticals DJB, Inc. | 39822-2000 | 39822-2000-01 |
| Clonidine | Clonidine hydrochloride 500 ug/mL | Injection, SolutionEpidural | XGen Pharmaceuticals DJB, Inc. | 39822-2010 | 39822-2010-01 |
| Clonidine | Clonidine .2 mg/d | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-0872 | 00378-0872-99 |
| Clonidine | Clonidine .3 mg/d | PatchTransdermal | Mylan Pharmaceuticals Inc. | 0378-0873 | 00378-0873-99 |