Prescription drug · ANDA
Bisoprolol (Bisoprolol fumarate) NDC 63629-6907
Bisoprolol fumarate 10 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-6907-1 | 6362969070163629690701 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-6907-1)Marketed from Sep 14, 2023 | |
| 63629-6907-2 | 6362969070263629690702 | 120 TABLET, FILM COATED in 1 BOTTLE (63629-6907-2)Marketed from Jan 20, 2020 | |
| 63629-6907-3 | 6362969070363629690703 | 180 TABLET, FILM COATED in 1 BOTTLE (63629-6907-3)Marketed from Aug 17, 2020 | |
| 63629-6907-4 | 6362969070463629690704 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-6907-4)Marketed from Sep 14, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Bisoprolol
- Generic name (nonproprietary)
- bisoprolol fumarate
- Active ingredients
- Bisoprolol fumarate — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075474
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 63629-6907_c5361713-d587-4393-90a9-773cd77d232dSPL ID c5361713-d587-4393-90a9-773cd77d232dSPL set ID 7ec24259-0f37-4389-873b-e62267a21d67RxCUI 854901UNII UR59KN573L
- Pharmacologic class
- beta-Adrenergic Blocker
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
N463629690701followed by a unit qualifier and the quantityPackage 63629-6907-01. 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)
INDICATIONS AND USAGE Bisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.
Excerpt only. Read the full label for complete information.
About NDC 63629-6907
- What is NDC 63629-6907?
- 63629-6907 is the product NDC for Bisoprolol (bisoprolol fumarate), Bisoprolol fumarate 10 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bisoprolol (Bisoprolol fumarate).
- What is the active ingredient?
- Bisoprolol fumarate.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bisoprolol?
- 6 other product NDCs are listed under this name. See all Bisoprolol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bisoprolol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bisoprololbisoprolol fumarate | Bisoprolol fumarate 5 mg/1 | Tablet, Film coatedOral | Micro Labs Limited | 42571-470 | 42571-0470-0142571-0470-0542571-0470-30 |
| Bisoprololbisoprolol fumarate | Bisoprolol fumarate 10 mg/1 | Tablet, Film coatedOral | Micro Labs Limited | 42571-471 | 42571-0471-0142571-0471-0542571-0471-30 |
| Bisoprololbisoprolol fumarate | Bisoprolol fumarate 5 mg/1 | Tablet, Film coatedOral | TruPharma, LLC | 52817-270 | 52817-0270-1052817-0270-30 |
| Bisoprololbisoprolol fumarate | Bisoprolol fumarate 10 mg/1 | Tablet, Film coatedOral | TruPharma, LLC | 52817-271 | 52817-0271-1052817-0271-30 |
| Bisoprololbisoprolol fumarate | Bisoprolol fumarate 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1678 | 71335-1678-0171335-1678-0271335-1678-03+2 more |
| Bisoprololbisoprolol fumarate | Bisoprolol fumarate 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2177 | 72162-2177-01 |
Other NDCs under ANDA 075474
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 |
|---|---|---|---|---|
| Bisoprololbisoprolol fumarate | Bisoprolol fumarate 5 mg/1 | Tablet, Film coatedOral | TruPharma, LLC | 52817-270 |
| Bisoprololbisoprolol fumarate | Bisoprolol fumarate 10 mg/1 | Tablet, Film coatedOral | TruPharma, LLC | 52817-271 |
| Bisoprololbisoprolol fumarate | Bisoprolol fumarate 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1678 |
| Bisoprololbisoprolol fumarate | Bisoprolol fumarate 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2177 |