Prescription drug · ANDA
clonidine hydrochloride NDC 46708-308
Clonidine hydrochloride .3 mg/1 · Tablet · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-308-10 | 46708030810 | 100 TABLET in 1 CARTON (46708-308-10)Marketed from May 3, 2016 | |
| 46708-308-30 | 46708030830 | 30 TABLET in 1 BOTTLE (46708-308-30)Marketed from May 3, 2016 | |
| 46708-308-31 | 46708030831 | 100 TABLET in 1 BOTTLE (46708-308-31)Marketed from May 3, 2016 | |
| 46708-308-71 | 46708030871 | 500 TABLET in 1 BOTTLE (46708-308-71)Marketed from May 3, 2016 | |
| 46708-308-91 | 46708030891 | 1000 TABLET in 1 BOTTLE (46708-308-91)Marketed from May 3, 2016 |
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 hydrochloride
- Generic name (nonproprietary)
- clonidine hydrochloride
- Active ingredients
- Clonidine hydrochloride — .3 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091368
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 46708-308_f2ae3ce9-d436-4616-a3eb-7838af98b9a6SPL ID f2ae3ce9-d436-4616-a3eb-7838af98b9a6SPL set ID 88a8db46-0fc9-48cd-b7cc-ac9c9cdea100RxCUI 884173, 884185, 884189UNII W76I6XXF06UPC 0346708307301, 0346708306304, 0346708308308
- 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
N446708030810followed by a unit qualifier and the quantityPackage 46708-0308-10. 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 Clonidine hydrochloride is indicated in the treatment of hypertension. Clonidine hydrochloride may be employed alone or concomitantly with other antihypertensive agents.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091368
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 hydrochloride | Clonidine hydrochloride .2 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8080 |
| clonidine hydrochloride | Clonidine hydrochloride .2 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3016 |
| clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2210 |
| clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7145 |
| clonidine hydrochloride | Clonidine hydrochloride .05 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-169 |
| clonidine hydrochloride | Clonidine hydrochloride .3 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8163 |
| clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1035 |
| clonidine hydrochloride | Clonidine hydrochloride .2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1060 |
| clonidine hydrochloride | Clonidine hydrochloride .2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1495 |
| clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | VERITYRX, LLC | 83939-0005 |
| clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-091 |
| clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-306 |
| clonidine hydrochloride | Clonidine hydrochloride .3 mg/1 | TabletOral | Coupler LLC | 67046-0646 |
| clonidine hydrochloride | Clonidine hydrochloride .2 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-307 |
| Clonidine Hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | DirectRX | 61919-605 |
| clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | A-S Medication Solutions | 50090-7475 |
| clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | A-S Medication Solutions | 50090-7477 |
| clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | Redpharm Drug | 67296-2260 |
| clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-066 |
| clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-057 |
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