Prescription drug · ANDA
Desipramine Hydrochloride NDC 46708-316
Desipramine hydrochloride 25 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-316-30 | 46708031630 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-316-30)Marketed from Jul 8, 2021 | |
| 46708-316-31 | 46708031631 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-316-31)Marketed from Jul 8, 2021 | |
| 46708-316-91 | 46708031691 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-316-91)Marketed from Jul 8, 2021 |
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)
- Desipramine Hydrochloride
- Generic name (nonproprietary)
- desipramine hydrochloride
- Active ingredients
- Desipramine hydrochloride — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209785
- Marketing start
- Listing expires
- Identifiers
- Product ID 46708-316_878a2586-20af-4f35-8908-82474cc732a3SPL ID 878a2586-20af-4f35-8908-82474cc732a3SPL set ID 8b6d2289-aac9-4007-a73d-c168fd2e1d9eRxCUI 1099288, 1099292, 1099296, 1099300, 1099304, 1099316UNII 1Y58DO4MY1UPC 0346708315306
- Pharmacologic class
- Tricyclic Antidepressant
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
N446708031630followed by a unit qualifier and the quantityPackage 46708-0316-30. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Desipramine hydrochloride tablets, USP are indicated for the treatment of depression.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209785
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 |
|---|---|---|---|---|
| Desipramine Hydrochloride | Desipramine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-315 |
| Desipramine Hydrochloride | Desipramine hydrochloride 150 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-320 |
| Desipramine Hydrochloride | Desipramine hydrochloride 50 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-317 |
| Desipramine Hydrochloride | Desipramine hydrochloride 75 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-318 |
| Desipramine Hydrochloride | Desipramine hydrochloride 100 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-319 |
| Desipramine Hydrochloride | Desipramine hydrochloride 50 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-317 |
| Desipramine Hydrochloride | Desipramine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-315 |
| Desipramine Hydrochloride | Desipramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-316 |
| Desipramine Hydrochloride | Desipramine hydrochloride 75 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-318 |
| Desipramine Hydrochloride | Desipramine hydrochloride 100 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-319 |
| Desipramine Hydrochloride | Desipramine hydrochloride 150 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-320 |