Prescription drug · ANDA

Clonidine Hydrochloride NDC 63629-2319

Clonidine hydrochloride .3 mg/1 · Tablet · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)63629-2319Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-2319Add 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
63629-2319-16362923190163629231901100 TABLET in 1 BOTTLE (63629-2319-1)Marketed from Jul 1, 2020

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
Bryant Ranch PrepackNDC labeler code 63629
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 63629-2319_1ac875e0-f409-4d6a-b4e0-31c721899f20SPL ID 1ac875e0-f409-4d6a-b4e0-31c721899f20SPL set ID 029ed62c-67cb-406f-84e4-702aebfa7d68RxCUI 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

N463629231901 followed by a unit qualifier and the quantity

Package 63629-2319-01. 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)

About NDC 63629-2319

What is NDC 63629-2319?
63629-2319 is the product NDC for Clonidine Hydrochloride, Clonidine hydrochloride .3 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. 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?
Bryant Ranch Prepack, NDC labeler code 63629. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Clonidine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
clonidine hydrochlorideClonidine hydrochloride .05 mg/1TabletOralAlembic Pharmaceuticals Inc.62332-16962332-0169-1062332-0169-3062332-0169-31+3 more
clonidine hydrochlorideClonidine hydrochloride .3 mg/1TabletOralCoupler LLC67046-064667046-0646-03
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralUnit Dose Solutions, Inc.87441-02487441-0024-01
Clonidine hydrochlorideClonidine hydrochloride .1 mg/1TabletOralUnit Dose Solutions, Inc.87441-02387441-0023-01
Clonidine hydrochlorideClonidine hydrochloride .05 mg/1TabletOralTruPharma, LLC52817-18352817-0183-10
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralMajor Pharmaceuticals0904-744300904-7443-61
Clonidine HydrochlorideClonidine hydrochloride .1 mg/1TabletOralCardinal Health 107, LLC55154-018955154-0189-00
Clonidine HydrochlorideClonidine hydrochloride .3 mg/1TabletOralREMEDYREPACK INC.70518-437970518-4379-00
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralREMEDYREPACK INC.70518-435770518-4357-00
Clonidine HydrochlorideClonidine hydrochloride .1 mg/1TabletOralREMEDYREPACK INC.70518-434270518-4342-0070518-4342-01

All 141 Clonidine Hydrochloride NDCs

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 Prepack71335-9682
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralBryant Ranch Prepack72162-1680
Clonidine HydrochlorideClonidine hydrochloride .1 mg/1TabletOralBryant Ranch Prepack72162-1679
Clonidine HydrochlorideClonidine hydrochloride .1 mg/1TabletOralMethod Pharmaceuticals, LLC58657-647
Clonidine HydrochlorideClonidine hydrochloride .3 mg/1TabletOralBryant Ranch Prepack72162-1681
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralMethod Pharmaceuticals, LLC58657-648
Clonidine HydrochlorideClonidine hydrochloride .3 mg/1TabletOralMethod Pharmaceuticals, LLC58657-649
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralBryant Ranch Prepack63629-2317
Clonidine HydrochlorideClonidine hydrochloride .1 mg/1TabletOralBryant Ranch Prepack63629-2314
Clonidine HydrochlorideClonidine hydrochloride .1 mg/1TabletOralBryant Ranch Prepack63629-2315
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralBryant Ranch Prepack63629-2316
Clonidine HydrochlorideClonidine hydrochloride .3 mg/1TabletOralBryant Ranch Prepack63629-2318
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralREMEDYREPACK INC.70518-3295
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralCoupler LLC67046-1552
Clonidine HydrochlorideClonidine hydrochloride .3 mg/1TabletOralBryant Ranch Prepack71335-2889
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralBryant Ranch Prepack63629-9269
Clonidine HydrochlorideClonidine hydrochloride .2 mg/1TabletOralBryant Ranch Prepack71335-2692
Clonidine HydrochlorideClonidine hydrochloride .3 mg/1TabletOralREMEDYREPACK INC.70518-4379
Clonidine HydrochlorideClonidine hydrochloride .1 mg/1TabletOralBryant Ranch Prepack71335-2489

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