Prescription drug · NDA AUTHORIZED GENERIC
dapagliflozin and metformin hydrochloride NDC 66993-361
Dapagliflozin propanediol 5 mg/1; Metformin hydrochloride 1000 mg/1 · Tablet, Film coated, Extended release · Oral · Prasco Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66993-361-60 | 6699303616066993036160 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (66993-361-60)Marketed from Jan 3, 2024 |
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 propanediol — 5 mg/1Metformin hydrochloride — 1000 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Prasco LaboratoriesNDC labeler code 66993
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 205649
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)Sodium-Glucose Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 66993-361_8954a9fe-fbb8-4d24-949a-85ae4bfb7ba5SPL ID 8954a9fe-fbb8-4d24-949a-85ae4bfb7ba5SPL set ID eaf135b6-e378-4f62-a1e7-db45e23668c7RxCUI 1593058, 1593070UNII 786Z46389E, 887K2391VH
- 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
N466993036160followed by a unit qualifier and the quantityPackage 66993-0361-60. 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 HCl extended-release tablets are a combination of dapagliflozin and metformin hydrochloride (HCl) extended-release, indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Dapagliflozin, when used as a component of Dapagliflozin and Metformin HCl extended-release tablets, is 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 fo…
Excerpt only. Read the full label for complete information.
About NDC 66993-361
- What is NDC 66993-361?
- 66993-361 is the product NDC for dapagliflozin and metformin hydrochloride, Dapagliflozin propanediol 5 mg/1; Metformin hydrochloride 1000 mg/1 tablet, film coated, extended release, listed with the FDA by Prasco Laboratories. It has 1 package NDC, 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 propanediol, Metformin hydrochloride.
- Who is the labeler?
- Prasco Laboratories, NDC labeler code 66993. 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 NDA 205649
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 propanediol 10 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Prasco Laboratories | 66993-362 |
| Xigduo XRdapagliflozin and metformin hydrochloride | Dapagliflozin propanediol 2.5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | AstraZeneca Pharmaceuticals LP | 0310-6225 |
| Xigduo XRdapagliflozin and metformin hydrochloride | Dapagliflozin propanediol 5 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | AstraZeneca Pharmaceuticals LP | 0310-6250 |
| Xigduo XRdapagliflozin and metformin hydrochloride | Dapagliflozin propanediol 5 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | AstraZeneca Pharmaceuticals LP | 0310-6260 |
| Xigduo XRdapagliflozin and metformin hydrochloride | Dapagliflozin propanediol 10 mg/1; Metformin hydrochloride 500 mg/1 | Tablet, Film coated, Extended releaseOral | AstraZeneca Pharmaceuticals LP | 0310-6270 |
| Xigduo XRdapagliflozin and metformin hydrochloride | Dapagliflozin propanediol 10 mg/1; Metformin hydrochloride 1000 mg/1 | Tablet, Film coated, Extended releaseOral | AstraZeneca Pharmaceuticals LP | 0310-6280 |