Prescription drug · ANDA
Imipramine Hydrochloride NDC 64380-171
Imipramine hydrochloride 50 mg/1 · Tablet · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-171-01 | 64380017101 | 100 TABLET in 1 BOTTLE, PLASTIC (64380-171-01)Marketed from Apr 11, 2022 | |
| 64380-171-02 | 64380017102 | 1000 TABLET in 1 BOTTLE, PLASTIC (64380-171-02)Marketed from Apr 11, 2022 |
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)
- Imipramine Hydrochloride
- Generic name (nonproprietary)
- imipramine hydrochloride
- Active ingredients
- Imipramine hydrochloride — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Strides Pharma Science LimitedNDC labeler code 64380
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 088276
- Marketing start
- Listing expires
- Identifiers
- Product ID 64380-171_567e586c-d32c-4362-b75f-a2c3a5a19352SPL ID 567e586c-d32c-4362-b75f-a2c3a5a19352SPL set ID 51d3b181-0d15-4782-a966-feb137972b18RxCUI 835564, 835568, 835593UNII BKE5Q1J60UUPC 0364380169024, 0364380170013, 0364380169017, 0364380171010, 0364380171027, 0364380170020
- 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
N464380017101followed by a unit qualifier and the quantityPackage 64380-0171-01. 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 64380-171
- What is NDC 64380-171?
- 64380-171 is the product NDC for Imipramine Hydrochloride, Imipramine hydrochloride 50 mg/1 tablet, listed with the FDA by Strides Pharma Science Limited. It has 2 package NDCs, 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?
- Strides Pharma Science Limited, NDC labeler code 64380. 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 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 |