Prescription drug · ANDA
Midodrine Hydrochloride NDC 60505-1321
Midodrine hydrochloride 5 mg/1 · Tablet · Oral · Apotex Corp
NDC codes
FDA NDC DirectoryProduct NDC (as listed)60505-1321Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60505-1321Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-1321-1 | 6050513210160505132101 | 100 TABLET in 1 BOTTLE (60505-1321-1)Marketed from Sep 12, 2006 | |
| 60505-1321-3 | 6050513210360505132103 | 30 TABLET in 1 BOTTLE (60505-1321-3)Marketed from Sep 12, 2006 | |
| 60505-1321-5 | 6050513210560505132105 | 500 TABLET in 1 BOTTLE (60505-1321-5)Marketed from Sep 12, 2006 | |
| 60505-1321-8 | 6050513210860505132108 | 1000 TABLET in 1 BOTTLE (60505-1321-8)Marketed from Sep 12, 2006 |
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)
- Midodrine Hydrochloride
- Generic name (nonproprietary)
- midodrine hydrochloride
- Active ingredients
- Midodrine hydrochloride — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Apotex CorpNDC labeler code 60505
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077746
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)
- Identifiers
- Product ID 60505-1321_37cdf8aa-c360-c39d-9b9c-a888ce26b6fbSPL ID 37cdf8aa-c360-c39d-9b9c-a888ce26b6fb
- Pharmacologic class
- alpha-Adrenergic Agonist
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
N460505132101followed by a unit qualifier and the quantityPackage 60505-1321-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 60505-1321
- What is NDC 60505-1321?
- 60505-1321 is the product NDC for Midodrine Hydrochloride, Midodrine hydrochloride 5 mg/1 tablet, listed with the FDA by Apotex Corp. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Midodrine Hydrochloride.
- What is the active ingredient?
- Midodrine hydrochloride.
- Who is the labeler?
- Apotex Corp, NDC labeler code 60505. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Midodrine Hydrochloride?
- 108 other product NDCs are listed under this name. See all Midodrine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Midodrine 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) |
|---|---|---|---|---|---|
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7640 | 00904-7640-0600904-7640-61 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7641 | 00904-7641-0600904-7641-61 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7642 | 00904-7642-07 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | NorthStar RxLLC | 72603-906 | 72603-0906-0572603-0906-10 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | NorthStar RxLLC | 72603-907 | 72603-0907-0572603-0907-10 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | NorthStar RxLLC | 72603-908 | 72603-0908-0372603-0908-05 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | Avet Pharmaceuticals Inc. | 23155-969 | 23155-0969-01 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Avet Pharmaceuticals Inc. | 23155-970 | 23155-0970-01 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | Avet Pharmaceuticals Inc. | 23155-971 | 23155-0971-01 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Safecor Health LLC | 48433-075 | 48433-0075-20 |
Other NDCs under ANDA 077746
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 |
|---|---|---|---|---|
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6817 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6818 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6819 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | AvKARE | 42291-560 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | AvKARE | 42291-561 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | AvKARE | 42291-562 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | AvPAK | 50268-561 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | AvPAK | 50268-562 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | AvPAK | 50268-563 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-4174 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-8086 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | Apotex Corp | 60505-1320 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | Apotex Corp | 60505-1325 |
| Midodrine Hydrochloride | Midodrine hydrochloride 2.5 mg/1 | TabletOral | American Health Packaging | 60687-387 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | American Health Packaging | 60687-398 |
| Midodrine Hydrochloride | Midodrine hydrochloride 10 mg/1 | TabletOral | American Health Packaging | 60687-409 |
| Midodrine Hydrochloride | Midodrine hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1433 |