Metformin Hydrochloride NDC 29300-389

NDC codes

FDA NDC Directory

Product NDC (as listed)29300-389Labeler and product segments. Claims need a package NDC.

Product NDC at billing width29300-0389Add 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
29300-389-01	29300038901	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-389-01)Marketed from Aug 11, 2021
29300-389-05	29300038905	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-389-05)Marketed from Aug 11, 2021
29300-389-10	29300038910	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-389-10)Marketed from Aug 11, 2021
29300-389-19	29300038919	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (29300-389-19)Marketed from Aug 11, 2021

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 Hydrochloride
Generic name (nonproprietary): metformin hydrochloride
Active ingredients: Metformin hydrochloride — 500 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Unichem Pharmaceuticals (USA), Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213359
Marketing start: Aug 11, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 29300-389_5aa6b7f2-64af-4f68-808d-9086edbf4d5eSPL ID 5aa6b7f2-64af-4f68-808d-9086edbf4d5eSPL set ID 9eebed09-2562-4d21-b3b3-c06562fe3f99RxCUI 860975, 860981UNII 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

N429300038901 followed by a unit qualifier and the quantity

Package 29300-0389-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 213359

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

FDA NDC Directory listings under ANDA 213359
Product	Strength	Form · route	Labeler	Product NDC
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Unichem Pharmaceuticals (USA), Inc.	29300-399