What is NDC 42571-322?

42571-322 is the product NDC for Dapagliflozin and Metformin Hydrochloride, Dapagliflozin 5 mg/1; Metformin hydrochloride 1000 mg/1 tablet, film coated, extended release, listed with the FDA by Micro Labs Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Dapagliflozin, Metformin hydrochloride.

Micro Labs Limited, NDC labeler code 42571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Dapagliflozin and Metformin Hydrochloride?

31 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dapagliflozin and Metformin Hydrochloride NDC 42571-322

NDC codes

FDA NDC Directory

Product NDC (as listed)42571-322Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42571-0322Add 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
42571-322-30	42571032230	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-322-30)Marketed from Oct 1, 2026
42571-322-60	42571032260	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-322-60)Marketed from Oct 1, 2026
42571-322-90	42571032290	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-322-90)Marketed from Oct 1, 2026

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): Dapagliflozin and Metformin Hydrochloride
Generic name (nonproprietary): dapagliflozin and metformin hydrochloride
Active ingredients: Dapagliflozin — 5 mg/1Metformin hydrochloride — 1000 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Micro Labs LimitedNDC labeler code 42571
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211466
Marketing start: Oct 1, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 42571-322_4f01ca78-24ac-c371-e063-6294a90a021cSPL ID 4f01ca78-24ac-c371-e063-6294a90a021c
Pharmacologic class: Biguanide; Sodium-Glucose Cotransporter 2 Inhibitor

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

N442571032230 followed by a unit qualifier and the quantity

Package 42571-0322-30. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 42571-322

What is NDC 42571-322?: 42571-322 is the product NDC for Dapagliflozin and Metformin Hydrochloride, Dapagliflozin 5 mg/1; Metformin hydrochloride 1000 mg/1 tablet, film coated, extended release, listed with the FDA by Micro Labs Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dapagliflozin and Metformin Hydrochloride.
What is the active ingredient?: Dapagliflozin, Metformin hydrochloride.
Who is the labeler?: Micro Labs Limited, NDC labeler code 42571. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dapagliflozin and Metformin Hydrochloride?: 31 other product NDCs are listed under this name. See all Dapagliflozin and 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 Dapagliflozin and Metformin Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Dapagliflozin and Metformin Hydrochloride	Dapagliflozin 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Micro Labs Limited	42571-320	42571-0320-0542571-0320-3042571-0320-90
Dapagliflozin and Metformin Hydrochloride	Dapagliflozin 10 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Micro Labs Limited	42571-321	42571-0321-0542571-0321-3042571-0321-90
Dapagliflozin and Metformin Hydrochloride	Dapagliflozin 10 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Micro Labs Limited	42571-323	42571-0323-0442571-0323-3042571-0323-90
Dapagliflozin And Metformin Hydrochloride	Dapagliflozin 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Lupin Pharmaceuticals, Inc.	70748-101	70748-0101-06
Dapagliflozin And Metformin Hydrochloride	Dapagliflozin 5 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Extended releaseOral	Lupin Pharmaceuticals, Inc.	70748-102	70748-0102-07
Dapagliflozin And Metformin Hydrochloride	Dapagliflozin 10 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Lupin Pharmaceuticals, Inc.	70748-103	70748-0103-06
Dapagliflozin And Metformin Hydrochloride	Dapagliflozin 10 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Extended releaseOral	Lupin Pharmaceuticals, Inc.	70748-104	70748-0104-06
Dapagliflozin and Metformin Hydrochloride	Dapagliflozin 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-406	33342-0406-0633342-0406-0733342-0406-09+2 more
Dapagliflozin and Metformin Hydrochloride	Dapagliflozin 10 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-407	33342-0407-0633342-0407-0733342-0407-09+2 more
Dapagliflozin and Metformin Hydrochloride	Dapagliflozin 5 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-408	33342-0408-0633342-0408-0733342-0408-09+2 more

All 32 Dapagliflozin and Metformin Hydrochloride NDCs

Other NDCs under ANDA 211466

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

FDA NDC Directory listings under ANDA 211466
Product	Strength	Form · route	Labeler	Product NDC
Dapagliflozin and Metformin Hydrochloride	Dapagliflozin 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Micro Labs Limited	42571-320
Dapagliflozin and Metformin Hydrochloride	Dapagliflozin 10 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	Micro Labs Limited	42571-321
Dapagliflozin and Metformin Hydrochloride	Dapagliflozin 10 mg/1; Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Micro Labs Limited	42571-323