Prescription drug · ANDA
Dapagliflozin NDC 67877-608
Dapagliflozin 5 mg/1 · Tablet, Film coated · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-608-05 | 6787706080567877060805 | 500 TABLET, FILM COATED in 1 BOTTLE (67877-608-05)Marketed from Apr 6, 2026 | |
| 67877-608-30 | 6787706083067877060830 | 30 TABLET, FILM COATED in 1 BOTTLE (67877-608-30)Marketed from Apr 6, 2026 | |
| 67877-608-33 | 6787706083367877060833 | 1 BLISTER PACK in 1 CARTON (67877-608-33) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 6, 2026 | |
| 67877-608-90 | 6787706089067877060890 | 90 TABLET, FILM COATED in 1 BOTTLE (67877-608-90)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
- Generic name (nonproprietary)
- dapagliflozin
- Active ingredients
- Dapagliflozin — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Ascend Laboratories, LLCNDC labeler code 67877
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211545
- Marketing start
- Listing expires
- Other FDA classes
- Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 67877-608_64617eef-d520-422b-aa99-d259b60c865fSPL ID 64617eef-d520-422b-aa99-d259b60c865f
- 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
N467877060805followed by a unit qualifier and the quantityPackage 67877-0608-05. 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 67877-608
- What is NDC 67877-608?
- 67877-608 is the product NDC for Dapagliflozin, Dapagliflozin 5 mg/1 tablet, film coated, 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.
- What is the active ingredient?
- Dapagliflozin.
- 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?
- 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 211545
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 10 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-609 |