What is NDC 63629-8757?

63629-8757 is the product NDC for Hydralazine Hydrochloride, Hydralazine hydrochloride 25 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.

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 Hydralazine Hydrochloride?

144 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Hydralazine Hydrochloride NDC 63629-8757

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-8757Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-8757Add 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 NDC	11-digit (billing)	Package	Copy
63629-8757-1	6362987570163629875701	1000 TABLET in 1 BOTTLE (63629-8757-1)Marketed from Aug 20, 2021

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): Hydralazine Hydrochloride
Generic name (nonproprietary): hydralazine hydrochloride
Active ingredients: Hydralazine hydrochloride — 25 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 088467
Marketing start: Sep 30, 1990
Listing expires: Dec 31, 2026
Other FDA classes: Arteriolar Vasodilation (Physiologic effect)
Identifiers: Product ID 63629-8757_3335c836-5e3d-4b72-b9d1-b3365cbe28b6SPL ID 3335c836-5e3d-4b72-b9d1-b3365cbe28b6SPL set ID 10f3e76e-9bba-4151-89fb-90d823a0a68cRxCUI 905225UNII FD171B778Y
Pharmacologic class: Arteriolar Vasodilator

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

N463629875701 followed by a unit qualifier and the quantity

Package 63629-8757-01. 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 Nov 8, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Essential hypertension, alone or as an adjunct.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-8757

What is NDC 63629-8757?: 63629-8757 is the product NDC for Hydralazine Hydrochloride, Hydralazine hydrochloride 25 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?: Hydralazine Hydrochloride.
What is the active ingredient?: Hydralazine 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 Hydralazine Hydrochloride?: 144 other product NDCs are listed under this name. See all Hydralazine 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 Hydralazine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Hydralazine Hydrochloride	Hydralazine hydrochloride 50 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0287	55154-0287-00
HydrALAZINE Hydrochloride	Hydralazine hydrochloride 50 mg/1	TabletOral	Coupler LLC	67046-2080	67046-2080-03
Hydralazine Hydrochloride	Hydralazine hydrochloride 10 mg/1	TabletOral	Safecor Health, LLC	48433-046	48433-0046-20
Hydralazine Hydrochloride	Hydralazine hydrochloride 25 mg/1	TabletOral	Safecor Health, LLC	48433-047	48433-0047-20
Hydralazine Hydrochloride	Hydralazine hydrochloride 50 mg/1	TabletOral	Safecor Health, LLC	48433-048	48433-0048-20
Hydralazine Hydrochloride	Hydralazine hydrochloride 25 mg/1	TabletOral	Coupler LLC	67046-1660	67046-1660-03
Hydralazine Hydrochloride	Hydralazine hydrochloride 20 mg/mL	InjectionIntramuscular, Intravenous	Navinta LLC	68475-514	68475-0514-02
Hydralazine Hydrochloride	Hydralazine hydrochloride 10 mg/1	TabletOral	Coupler LLC	67046-1609	67046-1609-03
Hydralazine Hydrochloride	Hydralazine hydrochloride 20 mg/mL	InjectionIntramuscular, Intravenous	Baxter Healthcare Corporation	43066-041	43066-0041-25
Hydralazine Hydrochloride	Hydralazine hydrochloride 25 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0186	55154-0186-00

All 145 Hydralazine Hydrochloride NDCs

Other NDCs under ANDA 088467

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

FDA NDC Directory listings under ANDA 088467
Product	Strength	Form · route	Labeler	Product NDC
Hydralazine Hydrochloride	Hydralazine hydrochloride 25 mg/1	TabletOral	Safecor Health, LLC	48433-047
Hydralazine Hydrochloride	Hydralazine hydrochloride 25 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	50111-327
Hydralazine Hydrochloride	Hydralazine hydrochloride 25 mg/1	TabletOral	Mylan Institutional Inc.	51079-075
Hydralazine Hydrochloride	Hydralazine hydrochloride 25 mg/1	TabletOral	Cardinal Health 107, LLC	55154-5689
Hydralazine Hydrochloride	Hydralazine hydrochloride 25 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	67544-657
Hydralazine Hydrochloride	Hydralazine hydrochloride 25 mg/1	TabletOral	Bryant Ranch Prepack	72162-1521