What is NDC 49483-622?

49483-622 is the product NDC for Metformin HCl, Metformin hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by TIME CAP LABORATORIES, INC. It has 4 package NDCs, shown above in 10- and 11-digit form.

TIME CAP LABORATORIES, INC, NDC labeler code 49483. 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 HCl?

32 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Metformin HCl NDC 49483-622 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)49483-622Labeler and product segments. Claims need a package NDC.

Product NDC at billing width49483-0622Add 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
49483-622-01	4948306220149483062201	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-622-01)Marketed from Nov 16, 2016
49483-622-10	4948306221049483062210	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-622-10)Marketed from Jun 5, 2017
49483-622-50	4948306225049483062250	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-622-50)Marketed from Nov 16, 2016
49483-622-81	4948306228149483062281	180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-622-81)Marketed from Jun 5, 2017

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): Metformin HCl
Generic name (nonproprietary): metformin hcl
Active ingredients: Metformin hydrochloride — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: TIME CAP LABORATORIES, INCNDC labeler code 49483
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090888
Marketing start: Nov 14, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 49483-622_2dc48b61-581f-fe5c-e063-6394a90aa557SPL ID 2dc48b61-581f-fe5c-e063-6394a90aa557SPL set ID 542cec22-eeae-4704-9bb6-4176640e5ea8RxCUI 861004, 861007, 861010UNII 786Z46389EUPC 0349483622102, 0349483621013, 0349483621105, 0349483621815, 0349483622812, 0349483620818, 0349483622010, 0349483620016
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

N449483062201 followed by a unit qualifier and the quantity

Package 49483-0622-01. 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 Feb 10, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Metformin Hydrochloride Tablets, USP is 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 Hydrochloride Tablet 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 49483-622

What is NDC 49483-622?: 49483-622 is the product NDC for Metformin HCl, Metformin hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by TIME CAP LABORATORIES, INC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Metformin HCl.
What is the active ingredient?: Metformin hydrochloride.
Who is the labeler?: TIME CAP LABORATORIES, INC, NDC labeler code 49483. 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 HCl?: 32 other product NDCs are listed under this name. See all Metformin HCl 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 HCl NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-056	87441-0056-01
Metformin HCl	Metformin hydrochloride 1000 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-055	87441-0055-01
Metformin HCL	Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-658	72189-0658-3072189-0658-8272189-0658-90
Metformin HCl	Metformin hydrochloride 850 mg/1	TabletOral	REMEDYREPACK INC.	70518-4479	70518-4479-0070518-4479-01
Metformin HCL	Metformin hydrochloride 1000 mg/1	TabletOral	Direct_Rx	72189-635	72189-0635-82
Metformin HCL	Metformin hydrochloride 500 mg/1	TabletOral	Direct_Rx	72189-617	72189-0617-3072189-0617-82
Metformin HCl	Metformin hydrochloride 1000 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0435	80425-0435-0180425-0435-0280425-0435-03+1 more
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	Northwind Health Company, LLC	82868-049	82868-0049-6082868-0049-9082868-0049-98
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	QPharma, Inc.	42708-009	42708-0009-60
Metformin HCl	Metformin hydrochloride 1000 mg/1	TabletOral	QPharma, Inc.	42708-018	42708-0018-30

All 33 Metformin HCl NDCs

Other NDCs under ANDA 090888

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

FDA NDC Directory listings under ANDA 090888
Product	Strength	Form · route	Labeler	Product NDC
Metformin HCl	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	TIME CAP LABORATORIES, INC	49483-620
Metformin HCl	Metformin hydrochloride 850 mg/1	Tablet, Film coatedOral	TIME CAP LABORATORIES, INC	49483-621
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	Tablet, Film coatedOral	MARKSANS PHARMA LIMITED	25000-131
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	MARKSANS PHARMA LIMITED	25000-132
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	MARKSANS PHARMA LIMITED	25000-134