Prescription drug · ANDA
Dapagliflozin NDC 46708-393
Dapagliflozin 10 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-393-30 | 4670803933046708039330 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-393-30)Marketed from Apr 6, 2026 | |
| 46708-393-90 | 4670803939046708039390 | 90 TABLET, FILM COATED in 1 BOTTLE (46708-393-90)Marketed from Apr 20, 2026 | |
| 46708-393-91 | 4670803939146708039391 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-393-91)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
- Generic name (nonproprietary)
- dapagliflozin
- Active ingredients
- Dapagliflozin — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211560
- Marketing start
- Listing expires
- Other FDA classes
- Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 46708-393_b7ee2d7a-a8ad-468a-9a6d-199131961f76SPL ID b7ee2d7a-a8ad-468a-9a6d-199131961f76SPL set ID d44f7eed-dd51-40d1-8408-8fb331e1f1f6RxCUI 1488569, 1488574UNII 1ULL0QJ8UCUPC 0346708393304, 0346708392307
- Pharmacologic class
- 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
N446708039330followed by a unit qualifier and the quantityPackage 46708-0393-30. 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 .
Indications (excerpt from the label)
Dapagliflozin tablets are indicated: • To reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. • As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use • Dapagliflozin tablets are not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus [see Warnings and Precautions (5.1)]. • Dapagliflozin tablets are not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 45 mL/min/1.73 m 2 . Dapagliflozin tablets are l…
Excerpt only. Read the full label for complete information.
About NDC 46708-393
- What is NDC 46708-393?
- 46708-393 is the product NDC for Dapagliflozin, Dapagliflozin 10 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dapagliflozin.
- What is the active ingredient?
- Dapagliflozin.
- Who is the labeler?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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?
- 46 other product NDCs are listed under this name. See all Dapagliflozin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dapagliflozin 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 | Dapagliflozin 5 mg/1 | TabletOral | Micro Labs Limited | 42571-317 | 42571-0317-1042571-0317-3042571-0317-90 |
| Dapagliflozin | Dapagliflozin 10 mg/1 | TabletOral | Micro Labs Limited | 42571-318 | 42571-0318-1042571-0318-3042571-0318-90 |
| Dapagliflozin | Dapagliflozin 5 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-072 | 73190-0072-3073190-0072-90 |
| Dapagliflozin | Dapagliflozin 10 mg/1 | Tablet, Film coatedOral | AvKARE | 73190-073 | 73190-0073-3073190-0073-90 |
| Dapagliflozin | Dapagliflozin 5 mg/1 | Tablet, Film coatedOral | ANI Pharmaceuticals, Inc. | 70954-856 | 70954-0856-10 |
| Dapagliflozin | Dapagliflozin 10 mg/1 | Tablet, Film coatedOral | ANI Pharmaceuticals, Inc. | 70954-857 | 70954-0857-10 |
| Dapagliflozin | Dapagliflozin 2,3-butanediol monohydrate 5 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-023 | 70377-0023-1170377-0023-12 |
| Dapagliflozin | Dapagliflozin 2,3-butanediol monohydrate 10 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc. | 70377-024 | 70377-0024-1170377-0024-12 |
| Dapagliflozin | Dapagliflozin 5 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3527 | 00480-3527-0500480-3527-5600480-3527-98 |
| Dapagliflozin | Dapagliflozin 10 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3528 | 00480-3528-0500480-3528-5600480-3528-98 |
Other NDCs under ANDA 211560
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 | Dapagliflozin 5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-392 |
| Dapagliflozin | Dapagliflozin 5 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-392 |
| Dapagliflozin | Dapagliflozin 10 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-393 |