Prescription drug · ANDA
Imipramine Hydrochloride NDC 50090-3148
Imipramine hydrochloride 25 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-3148-0 | 50090314800 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-3148-0)Marketed from Oct 3, 2017 |
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)
- Imipramine Hydrochloride
- Generic name (nonproprietary)
- imipramine hydrochloride
- Active ingredients
- Imipramine hydrochloride — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040903
- Marketing start
- Listing expires
- Identifiers
- Product ID 50090-3148_598f2103-3499-4d69-8d0a-c64cb5b9fbbcSPL ID 598f2103-3499-4d69-8d0a-c64cb5b9fbbcSPL set ID d9dbcebe-9aba-4a93-a7b7-48d29e07d3c4RxCUI 835564UNII 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.
- NDC on a medical claim
N450090314800followed by a unit qualifier and the quantityPackage 50090-3148-00. 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 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 50090-3148
- What is NDC 50090-3148?
- 50090-3148 is the product NDC for Imipramine Hydrochloride, Imipramine hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Imipramine Hydrochloride.
- What is the active ingredient?
- Imipramine hydrochloride.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. 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 |
Other NDCs under ANDA 040903
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 Hydrochloride | Imipramine hydrochloride 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1588 |
| Imipramine Hydrochloride | Imipramine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-804 |
| Imipramine Hydrochloride | Imipramine hydrochloride 50 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-493 |
| Imipramine Hydrochloride | Imipramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-492 |
| Imipramine Hydrochloride | Imipramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2601 |
| Imipramine Hydrochloride | Imipramine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Leading Pharma, LLC | 69315-133 |
| Imipramine Hydrochloride | Imipramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Leading Pharma, LLC | 69315-134 |
| Imipramine Hydrochloride | Imipramine hydrochloride 50 mg/1 | Tablet, Film coatedOral | Leading Pharma, LLC | 69315-135 |
| Imipramine Hydrochloride | Imipramine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-3106 |
| Imipramine hydrochloride | Imipramine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0294 |
| Imipramine Hydrochloride | Imipramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1564 |