Prescription drug · ANDA
dapagliflozin and metformin hydrochloride NDC 67877-622
Dapagliflozin 10 mg/1; Metformin hydrochloride 1000 mg/1 · Tablet, Film coated, Extended release · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-622-30 | 6787706223067877062230 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-622-30)Marketed from Apr 6, 2026 | |
| 67877-622-38 | 6787706223867877062238 | 10 BLISTER PACK in 1 CARTON (67877-622-38) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Apr 6, 2026 | |
| 67877-622-40 | 6787706224067877062240 | 400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-622-40)Marketed from Apr 6, 2026 | |
| 67877-622-90 | 6787706229067877062290 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-622-90)Marketed from Apr 6, 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 — 10 mg/1Metformin hydrochloride — 1000 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Ascend Laboratories, LLCNDC labeler code 67877
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211563
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 67877-622_a54a2b85-619a-4bb8-b3fa-dfe945a9008dSPL ID a54a2b85-619a-4bb8-b3fa-dfe945a9008dSPL set ID eadcc3ef-f5c2-4a56-a6aa-12909844144eRxCUI 1593058, 1593068, 1593070, 1593072UNII 786Z46389E, 1ULL0QJ8UCUPC 0367877621050
- 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
N467877062230followed by a unit qualifier and the quantityPackage 67877-0622-30. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Dapagliflozin and metformin hydrochloride extended-release tablets are combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Dapagliflozin, when used as a component of dapagliflozin and metformin hydrochloride extended-release tablets, are indicated in adults with type 2 diabetes mellitus to reduce the risk of: Sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in patients with chronic kidney disease at risk of progression. Cardiovascular death, hospitalization for heart failure, and urgent hear…
Excerpt only. Read the full label for complete information.
About NDC 67877-622
- What is NDC 67877-622?
- 67877-622 is the product NDC for dapagliflozin and metformin hydrochloride, Dapagliflozin 10 mg/1; Metformin hydrochloride 1000 mg/1 tablet, film coated, extended release, listed with the FDA by Ascend Laboratories, LLC. It has 4 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?
- Ascend Laboratories, LLC, NDC labeler code 67877. 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.
Related NDCs: other dapagliflozin and metformin hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| 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, 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 5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Micro Labs Limited | 42571-322 | 42571-0322-3042571-0322-6042571-0322-90 |
| 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 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 |
Other NDCs under ANDA 211563
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 | Ascend Laboratories, LLC | 67877-619 |
| dapagliflozin and metformin hydrochloride | Dapagliflozin 5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Ascend Laboratories, LLC | 67877-620 |
| dapagliflozin and metformin hydrochloride | Dapagliflozin 10 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | Ascend Laboratories, LLC | 67877-621 |