Prescription drug · ANDA
Imipramine Pamoate NDC 0054-0275
Imipramine pamoate 125 mg/1 · Capsule · Oral · Hikma Pharmaceuticals USA Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0275-13 | 00054027513 | 30 CAPSULE in 1 BOTTLE (0054-0275-13)Marketed from Apr 19, 2010 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Imipramine Pamoate
- Generic name (nonproprietary)
- imipramine pamoate
- Active ingredients
- Imipramine pamoate — 125 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091099
- Marketing start
- Listing expires
- Identifiers
- Product ID 0054-0275_9c97ff7a-cee1-4c19-a52e-3f22798834fbSPL ID 9c97ff7a-cee1-4c19-a52e-3f22798834fbSPL set ID 6e780825-2a66-41fd-a04c-78fa7c4df05eRxCUI 835572, 835577, 835589, 835591UNII MC34P30298UPC 0300540274139, 0300540276133
- 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
N400054027513followed by a unit qualifier and the quantityPackage 00054-0275-13. 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 For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091099
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 |
|---|---|---|---|---|
| Imipramine Pamoate | Imipramine pamoate 75 mg/1 | CapsuleOral | Hikma Pharmaceuticals USA Inc | 0054-0273 |
| Imipramine Pamoate | Imipramine pamoate 150 mg/1 | CapsuleOral | Hikma Pharmaceuticals USA Inc | 0054-0276 |
| Imipramine Pamoate | Imipramine pamoate 100 mg/1 | CapsuleOral | Hikma Pharmaceuticals USA Inc | 0054-0274 |