Prescription drug · ANDA

Clonidine Hydrochloride NDC 43547-567

Clonidine hydrochloride .3 mg/1 · Tablet · Oral · Solco Healthcare LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)43547-567Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43547-0567Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
43547-567-1043547056710100 TABLET in 1 BOTTLE, PLASTIC (43547-567-10)Marketed from Jan 5, 2023

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 077901
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha2-Agonists (Mechanism)
Identifiers
Product ID 43547-567_d09551ff-dfac-4525-8122-97b4463e98eaSPL ID d09551ff-dfac-4525-8122-97b4463e98eaSPL set ID 2bbfea75-9241-4c3a-84f5-342ccb3cdf16RxCUI 884173, 884185, 884189UNII W76I6XXF06UPC 0343547567101, 0343547565107, 0343547566104
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

N443547056710 followed by a unit qualifier and the quantity

Package 43547-0567-10. 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 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077901

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 077901
ProductStrengthForm · routeLabelerProduct NDC
Clonidine HydrochlorideClonidine hydrochloride .1 mg/1TabletOralSolco Healthcare LLC43547-565
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralSolco Healthcare LLC43547-566
Clonidine HydrochlorideClonidine hydrochloride .1 mg/1TabletOralCardinal Health 107, LLC55154-0189
Clonidine HydrochlorideClonidine hydrochloride .1 mg/1TabletOralMajor Pharmaceuticals0904-7442
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralMajor Pharmaceuticals0904-7443

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Clonidine Hydrochloride NDC 43547-567 | Med-Code