Prescription drug · ANDA
Imipramine Hydrochloride NDC 68180-311
Imipramine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Imipramine Hydrochloride
- Generic name (nonproprietary)
- imipramine hydrochloride
- Active ingredients
- Imipramine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.NDC labeler code 68180
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090443
- Marketing start
- Listing expires
- Identifiers
- Product ID 68180-311_b891d3a3-3346-441e-99cc-03528b4afa46SPL ID b891d3a3-3346-441e-99cc-03528b4afa46SPL set ID 55311747-710c-43c4-821d-76323ff2520eRxCUI 835564, 835568, 835593UNII BKE5Q1J60U
- 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.
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Depression 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. Childhood Enuresis May be useful as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older, after possible organic causes have been excluded by appropriate tests. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The effectiveness of treatment may decrease with continued drug administration.
Excerpt only. Read the full label for complete information.
About NDC 68180-311
- What is NDC 68180-311?
- 68180-311 is the product NDC for Imipramine Hydrochloride, Imipramine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Lupin Pharmaceuticals, Inc..
- What drug is associated with this NDC?
- Imipramine Hydrochloride.
- What is the active ingredient?
- Imipramine hydrochloride.
- Who is the labeler?
- Lupin Pharmaceuticals, Inc., NDC labeler code 68180. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Imipramine Hydrochloride?
- 30 other product NDCs are listed under this name. See all Imipramine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Imipramine 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) |
|---|---|---|---|---|---|
| Imipramine Hydrochloride | Imipramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1564 | 67046-1564-03 |
| Imipramine Hydrochloride | Imipramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0342 | 80425-0342-0180425-0342-0280425-0342-03 |
| Imipramine hydrochloride | Imipramine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0294 | 80425-0294-0180425-0294-0280425-0294-03 |
| Imipramine Hydrochloride | Imipramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Key Therapeutics | 70868-810 | 70868-0810-10 |
| Imipramine Hydrochloride | Imipramine hydrochloride 25 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-170 | 64380-0170-0164380-0170-02 |
| Imipramine Hydrochloride | Imipramine hydrochloride 10 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-169 | 64380-0169-0164380-0169-02 |
| Imipramine Hydrochloride | Imipramine hydrochloride 50 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-171 | 64380-0171-0164380-0171-02 |
| Imipramine Hydrochloride | Imipramine hydrochloride 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3526 | 70518-3526-0070518-3526-0170518-3526-03 |
| Imipramine Hydrochloride | Imipramine hydrochloride 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-244 | 72789-0244-01 |
| Imipramine Hydrochloride | Imipramine hydrochloride 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-240 | 72789-0240-0172789-0240-95 |