Prescription drug · ANDA
Clonidine Hydrochloride NDC 0904-7443
Clonidine hydrochloride .2 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7443-61 | 00904744361 | 100 BLISTER PACK in 1 CARTON (0904-7443-61) / 1 TABLET in 1 BLISTER PACKMarketed from Nov 21, 2025 |
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 Hydrochloride
- Generic name (nonproprietary)
- clonidine hydrochloride
- Active ingredients
- Clonidine hydrochloride — .2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077901
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)
- Identifiers
- Product ID 0904-7443_8dab11da-f83b-4794-b612-3817f7a609b4SPL ID 8dab11da-f83b-4794-b612-3817f7a609b4SPL set ID 8171776a-dd14-4dcc-8860-3c27d8ea9504RxCUI 884173, 884185UNII 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
N400904744361followed by a unit qualifier and the quantityPackage 00904-7443-61. 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 077901
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 | Solco Healthcare LLC | 43547-565 |
| Clonidine Hydrochloride | Clonidine hydrochloride .2 mg/1 | TabletOral | Solco Healthcare LLC | 43547-566 |
| Clonidine Hydrochloride | Clonidine hydrochloride .3 mg/1 | TabletOral | Solco Healthcare LLC | 43547-567 |
| Clonidine Hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0189 |
| Clonidine Hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7442 |