What is NDC 63629-8503?

63629-8503 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 1000 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 Metformin Hydrochloride?

358 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Metformin Hydrochloride NDC 63629-8503

NDC codes

FDA NDC Directory

Product NDC (as listed)63629-8503Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63629-8503Add 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
63629-8503-1	63629850301	500 TABLET in 1 BOTTLE (63629-8503-1)Marketed from May 18, 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): Metformin Hydrochloride
Generic name (nonproprietary): metformin hydrochloride
Active ingredients: Metformin hydrochloride — 1000 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 203769
Marketing start: Feb 1, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 63629-8503_df9541d1-769e-4b35-9da7-59fdad1632bfSPL ID df9541d1-769e-4b35-9da7-59fdad1632bfSPL set ID a79d2674-071f-4641-9b11-406e02c5530aRxCUI 861004UNII 786Z46389E
Pharmacologic class: Biguanide

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

N463629850301 followed by a unit qualifier and the quantity

Package 63629-8503-01. 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 Mar 10, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-8503

What is NDC 63629-8503?: 63629-8503 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 1000 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?: Metformin Hydrochloride.
What is the active ingredient?: Metformin 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 Metformin Hydrochloride?: 358 other product NDCs are listed under this name. See all Metformin 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 Metformin Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Marlex Pharmaceuticals, Inc.	10135-823	10135-0823-0510135-0823-1010135-0823-30+5 more
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Marlex Pharmaceuticals, Inc.	10135-824	10135-0824-0510135-0824-1010135-0824-90
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4185	68788-4185-0168788-4185-0368788-4185-06+3 more
Metformin Hydrochloride	Metformin hydrochloride 625 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-588	50228-0588-0550228-0588-30
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-589	50228-0589-0550228-0589-30
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4710	70518-4710-0070518-4710-02
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	REMEDYREPACK INC.	70518-4698	70518-4698-00
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0591	80425-0591-0180425-0591-0280425-0591-03+1 more
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-054	87441-0054-01
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4677	70518-4677-0070518-4677-01

All 359 Metformin Hydrochloride NDCs

Other NDCs under ANDA 203769

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

FDA NDC Directory listings under ANDA 203769
Product	Strength	Form · route	Labeler	Product NDC
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	43353-982
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	43353-987
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	A-S Medication Solutions	50090-7586
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	A-S Medication Solutions	50090-7587
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	A-S Medication Solutions	50090-7588
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-105
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-106
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-107
Metformin Hydrochloride	Metformin hydrochloride 625 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-588
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-589
Metformin Hydrochloride	Metformin hydrochloride 625 mg/1	TabletOral	Method Pharmaceuticals, LLC.	58657-726
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	TabletOral	Method Pharmaceuticals, LLC.	58657-727
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	Golden State Medical Supply, Inc.	60429-111
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	TabletOral	Golden State Medical Supply, Inc.	60429-112
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	Golden State Medical Supply, Inc.	60429-113
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	Bryant Ranch Prepack	63629-8501
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	Bryant Ranch Prepack	63629-8502
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	Bryant Ranch Prepack	63629-8504
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	Preferred Pharmaceuticals Inc	68788-4076
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Westminster Pharmaceuticals, LLC	69367-180

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