Prescription drug · ANDA

Clonidine Hydrochloride NDC 58657-649

Clonidine hydrochloride .3 mg/1 · Tablet · Oral · Method Pharmaceuticals, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)58657-649Labeler and product segments. Claims need a package NDC.
Product NDC at billing width58657-0649Add 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
58657-649-0158657064901100 TABLET in 1 BOTTLE (58657-649-01)Marketed from Jul 1, 2020
58657-649-10586570649101000 TABLET in 1 BOTTLE (58657-649-10)Marketed from Jul 1, 2020
58657-649-5058657064950500 TABLET in 1 BOTTLE (58657-649-50)Marketed from Jul 1, 2020

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 202297
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha2-Agonists (Mechanism)
Identifiers
Product ID 58657-649_2ea9750b-e90d-cc5b-e063-6394a90a7e78SPL ID 2ea9750b-e90d-cc5b-e063-6394a90a7e78SPL set ID dffb5fdd-06c0-4275-9f89-9e12b3adf8a9RxCUI 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

N458657064901 followed by a unit qualifier and the quantity

Package 58657-0649-01. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202297

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

FDA NDC Directory listings under ANDA 202297
ProductStrengthForm · routeLabelerProduct NDC
Clonidine HydrochlorideClonidine hydrochloride .3 mg/1TabletOralBryant Ranch Prepack71335-2889
Clonidine HydrochlorideClonidine hydrochloride .1 mg/1TabletOralMethod Pharmaceuticals, LLC58657-647
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralMethod Pharmaceuticals, LLC58657-648
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralBryant Ranch Prepack71335-2692
Clonidine HydrochlorideClonidine hydrochloride .1 mg/1TabletOralBryant Ranch Prepack63629-2315
Clonidine HydrochlorideClonidine hydrochloride .1 mg/1TabletOralBryant Ranch Prepack63629-2314
Clonidine HydrochlorideClonidine hydrochloride .3 mg/1TabletOralBryant Ranch Prepack63629-2319
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralBryant Ranch Prepack63629-2316
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralBryant Ranch Prepack63629-2317
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralCoupler LLC67046-1552
Clonidine HydrochlorideClonidine hydrochloride .3 mg/1TabletOralBryant Ranch Prepack63629-2318
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralREMEDYREPACK INC.70518-3295
Clonidine HydrochlorideClonidine hydrochloride .1 mg/1TabletOralBryant Ranch Prepack71335-2489
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralBryant Ranch Prepack63629-9269
Clonidine HydrochlorideClonidine hydrochloride .3 mg/1TabletOralBryant Ranch Prepack71335-9682
Clonidine HydrochlorideClonidine hydrochloride .3 mg/1TabletOralREMEDYREPACK INC.70518-4379
Clonidine HydrochlorideClonidine hydrochloride .1 mg/1TabletOralBryant Ranch Prepack72162-1679
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralBryant Ranch Prepack72162-1680
Clonidine HydrochlorideClonidine hydrochloride .3 mg/1TabletOralBryant Ranch Prepack72162-1681

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