Prescription drug · ANDA
Amitriptyline Hydrochloride NDC 68071-3656
Amitriptyline hydrochloride 25 mg/1 · Tablet · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)68071-3656Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-3656Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3656-3 | 6807136560368071365603 | 30 TABLET in 1 BOTTLE (68071-3656-3)Marketed from Jul 30, 2024 |
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)
- Amitriptyline Hydrochloride
- Generic name (nonproprietary)
- amitriptyline hydrochloride
- Active ingredients
- Amitriptyline hydrochloride — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals, Inc.NDC labeler code 68071
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217411
- Marketing start
- Listing expires
- Identifiers
- Product ID 68071-3656_1e78bc61-52f7-5a4c-e063-6394a90ab181SPL ID 1e78bc61-52f7-5a4c-e063-6394a90ab181SPL set ID 1e78e304-00e8-7cb3-e063-6294a90a87adRxCUI 856834UNII 26LUD4JO9KUPC 0368071365634
- 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
N468071365603followed by a unit qualifier and the quantityPackage 68071-3656-03. 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 For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.
Excerpt only. Read the full label for complete information.
About NDC 68071-3656
- What is NDC 68071-3656?
- 68071-3656 is the product NDC for Amitriptyline Hydrochloride, Amitriptyline hydrochloride 25 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amitriptyline Hydrochloride.
- What is the active ingredient?
- Amitriptyline hydrochloride.
- Who is the labeler?
- NuCare Pharmaceuticals, Inc., NDC labeler code 68071. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Amitriptyline Hydrochloride?
- 203 other product NDCs are listed under this name. See all Amitriptyline Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Amitriptyline 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) |
|---|---|---|---|---|---|
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 10 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-896 | 60760-0896-15 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1694 | 67046-1694-03 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0689 | 67046-0689-03 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 150 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1671 | 67046-1671-03 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0764 | 67046-0764-03 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1669 | 67046-1669-03 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-818 | 59651-0818-0159651-0818-99 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-819 | 59651-0819-0159651-0819-99 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 75 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-820 | 59651-0820-01 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-821 | 59651-0821-0159651-0821-60 |
Other NDCs under ANDA 217411
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 |
|---|---|---|---|---|
| Amitriptyline HCL | Amitriptyline hydrochloride 100 mg/1 | TabletOral | Direct_rx | 72189-581 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7410 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7411 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 10 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-105 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-106 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-107 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 75 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-108 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-109 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 150 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-110 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-7583 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-7598 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-685 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-686 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-732 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4052 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8691 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8767 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 75 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8788 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4048 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4054 |
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