Prescription drug · ANDA
Imipramine Hydrochloride NDC 67046-1564
Imipramine hydrochloride 25 mg/1 · Tablet, Film coated · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1564-3 | 67046156403 | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1564-3)Marketed from Jan 21, 2026 |
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
- Coupler LLCNDC labeler code 67046
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040903
- Marketing start
- Listing expires
- Identifiers
- Product ID 67046-1564_48e8b30a-0294-a5ed-e063-6394a90a8f01SPL ID 48e8b30a-0294-a5ed-e063-6394a90a8f01SPL set ID 48e8b819-a9a0-aa5a-e063-6394a90ad9c2RxCUI 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
N467046156403followed by a unit qualifier and the quantityPackage 67046-1564-03. 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 67046-1564
- What is NDC 67046-1564?
- 67046-1564 is the product NDC for Imipramine Hydrochloride, Imipramine hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Coupler LLC. 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?
- Coupler LLC, NDC labeler code 67046. 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 | 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 |
| Imipramine Hydrochloride | Imipramine hydrochloride 25 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-243 | 72789-0243-0172789-0243-95 |
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 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3148 |
| Imipramine hydrochloride | Imipramine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0294 |