Prescription drug · ANDA
clonidine hydrochloride NDC 46708-169
Clonidine hydrochloride .05 mg/1 · Tablet · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC DirectoryProduct NDC (as listed)46708-169Labeler and product segments. Claims need a package NDC.
Product NDC at billing width46708-0169Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-169-10 | 4670801691046708016910 | 100 BLISTER PACK in 1 CARTON (46708-169-10) / 10 TABLET in 1 BLISTER PACKMarketed from Sep 22, 2026 | |
| 46708-169-30 | 4670801693046708016930 | 30 TABLET in 1 BOTTLE (46708-169-30)Marketed from Sep 22, 2026 | |
| 46708-169-31 | 4670801693146708016931 | 100 TABLET in 1 BOTTLE (46708-169-31)Marketed from Sep 22, 2026 | |
| 46708-169-60 | 4670801696046708016960 | 60 TABLET in 1 BOTTLE (46708-169-60)Marketed from Sep 22, 2026 | |
| 46708-169-71 | 4670801697146708016971 | 500 TABLET in 1 BOTTLE (46708-169-71)Marketed from Sep 22, 2026 | |
| 46708-169-91 | 4670801699146708016991 | 1000 TABLET in 1 BOTTLE (46708-169-91)Marketed from Sep 22, 2026 |
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 — .05 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- 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 46708-169_cf493e6a-1603-4c7d-a442-69a119bec843SPL ID cf493e6a-1603-4c7d-a442-69a119bec843SPL set ID cf493e6a-1603-4c7d-a442-69a119bec843RxCUI 2740803UNII W76I6XXF06UPC 0346708169305
- 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
N446708016910followed by a unit qualifier and the quantityPackage 46708-0169-10. 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.
About NDC 46708-169
- What is NDC 46708-169?
- 46708-169 is the product NDC for clonidine hydrochloride, Clonidine hydrochloride .05 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 6 package NDCs, 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?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 .3 mg/1 | TabletOral | Coupler LLC | 67046-0646 | 67046-0646-03 |
| 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 |
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 .3 mg/1 | TabletOral | Coupler LLC | 67046-0646 |
| 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 |
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