Prescription drug · ANDA
Dapagliflozin and Metformin Hydrochloride NDC 63304-026
Dapagliflozin 5 mg/1; Metformin hydrochloride 1000 mg/1 · Tablet, Film coated, Extended release · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)63304-026Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63304-0026Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63304-026-30 | 6330400263063304002630 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-026-30)Marketed from Apr 6, 2026 | |
| 63304-026-54 | 6330400265463304002654 | 400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-026-54)Marketed from Apr 6, 2026 | |
| 63304-026-62 | 6330400266263304002662 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63304-026-62)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 — 5 mg/1Metformin hydrochloride — 1000 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 63304
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211491
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 63304-026_5bac1e03-5062-a6b3-e063-6394a90aacf6SPL ID 5bac1e03-5062-a6b3-e063-6394a90aacf6
- 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
N463304002630followed by a unit qualifier and the quantityPackage 63304-0026-30. 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 63304-026
- What is NDC 63304-026?
- 63304-026 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 Sun Pharmaceutical Industries, Inc.. 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?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 63304. 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 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 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 |
Other NDCs under ANDA 211491
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 10 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 63304-027 |
| Dapagliflozin and Metformin Hydrochloride | Dapagliflozin 10 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 63304-028 |
| Dapagliflozin and Metformin Hydrochloride | Dapagliflozin 5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Golden State Medical Supply, Inc. | 84677-020 |
| Dapagliflozin and Metformin Hydrochloride | Dapagliflozin 10 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | Golden State Medical Supply, Inc. | 84677-021 |
| Dapagliflozin and Metformin Hydrochloride | Dapagliflozin 10 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Golden State Medical Supply, Inc. | 84677-022 |