Prescription drug · ANDA
clonidine hydrochloride NDC 67046-0646
Clonidine hydrochloride .3 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-0646-3 | 6704606460367046064603 | 30 TABLET in 1 BLISTER PACK (67046-0646-3)Marketed from Aug 7, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Labeler
- Coupler LLCNDC labeler code 67046
- 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 67046-0646_58772ae8-be92-53cd-e063-6294a90a518aSPL ID 58772ae8-be92-53cd-e063-6294a90a518aSPL set ID 58772b44-dec0-7001-e063-6394a90ac40eRxCUI 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
N467046064603followed by a unit qualifier and the quantityPackage 67046-0646-03. 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.
About NDC 67046-0646
- What is NDC 67046-0646?
- 67046-0646 is the product NDC for clonidine hydrochloride, Clonidine hydrochloride .3 mg/1 tablet, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- clonidine hydrochloride.
- What is the active ingredient?
- Clonidine hydrochloride.
- Who is the labeler?
- Coupler LLC, NDC labeler code 67046. 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 hydrochloride?
- 140 other product NDCs are listed under this name. See all clonidine hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other clonidine hydrochloride 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 hydrochloride | Clonidine hydrochloride .05 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-169 | 62332-0169-1062332-0169-3062332-0169-31+3 more |
| Clonidine Hydrochloride | Clonidine hydrochloride .2 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-024 | 87441-0024-01 |
| Clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-023 | 87441-0023-01 |
| Clonidine hydrochloride | Clonidine hydrochloride .05 mg/1 | TabletOral | TruPharma, LLC | 52817-183 | 52817-0183-10 |
| Clonidine Hydrochloride | Clonidine hydrochloride .2 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7443 | 00904-7443-61 |
| Clonidine Hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0189 | 55154-0189-00 |
| Clonidine Hydrochloride | Clonidine hydrochloride .3 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4379 | 70518-4379-00 |
| Clonidine Hydrochloride | Clonidine hydrochloride .2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4357 | 70518-4357-00 |
| Clonidine Hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4342 | 70518-4342-0070518-4342-01 |
| clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-992 | 60760-0992-3060760-0992-90 |
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 .1 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-306 |
| clonidine hydrochloride | Clonidine hydrochloride .2 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-307 |
| clonidine hydrochloride | Clonidine hydrochloride .3 mg/1 | TabletOral | Alembic Pharmaceuticals Limited | 46708-308 |
| 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 | St. Mary's Medical Park Pharmacy | 60760-057 |
| Clonidine Hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | DirectRX | 61919-605 |
| clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-054 |
| clonidine hydrochloride | Clonidine hydrochloride .2 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-055 |
| clonidine hydrochloride | Clonidine hydrochloride .3 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-056 |
| clonidine hydrochloride | Clonidine hydrochloride .05 mg/1 | TabletOral | Alembic Pharmaceuticals Inc. | 62332-169 |
| clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | Redpharm Drug | 67296-2260 |
| clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2210 |
| clonidine hydrochloride | Clonidine hydrochloride .2 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3016 |
| clonidine hydrochloride | Clonidine hydrochloride .1 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7145 |
| clonidine hydrochloride | Clonidine hydrochloride .2 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8080 |
| 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 .1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0777 |
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