Prescription drug · ANDA
Clonidine hydrochloride NDC 76420-283
Clonidine hydrochloride .1 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-283-01 | 76420028301 | 100 TABLET in 1 BOTTLE (76420-283-01)Marketed from Sep 16, 2022 | |
| 76420-283-20 | 76420028320 | 20 TABLET in 1 BOTTLE (76420-283-20)Marketed from Sep 16, 2022 | |
| 76420-283-30 | 76420028330 | 30 TABLET in 1 BOTTLE (76420-283-30)Marketed from Sep 16, 2022 | |
| 76420-283-60 | 76420028360 | 60 TABLET in 1 BOTTLE (76420-283-60)Marketed from Sep 16, 2022 | |
| 76420-283-90 | 76420028390 | 90 TABLET in 1 BOTTLE (76420-283-90)Marketed from Sep 9, 2022 |
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 — .1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070925
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 76420-283_e8c7a94e-8d26-886a-e053-2995a90a1ad8SPL ID e8c7a94e-8d26-886a-e053-2995a90a1ad8SPL set ID e8c7aa08-1450-de68-e053-2995a90ad0b6RxCUI 884173, 884185, 884189UNII W76I6XXF06
- 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
N476420028301followed by a unit qualifier and the quantityPackage 76420-0283-01. 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 tablets USP are indicated in the treatment of hypertension. Clonidine hydrochloride tablets USP may be employed alone or concomitantly with other antihypertensive agents.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 070925
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 .1 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4545 |
| Clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0922 |
| Clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3987 |
| Clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-445 |
| Clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | Proficient Rx LP | 71205-588 |
| Clonidine Hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | Proficient Rx LP | 63187-202 |