Prescription drug · ANDA
Amitriptyline Hydrochloride NDC 71335-1254
Amitriptyline hydrochloride 25 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1254-0 | 71335125400 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1254-0)Marketed from Dec 28, 2021 | |
| 71335-1254-1 | 71335125401 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1254-1)Marketed from Dec 28, 2021 | |
| 71335-1254-2 | 71335125402 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1254-2)Marketed from Jul 19, 2019 | |
| 71335-1254-3 | 71335125403 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1254-3)Marketed from Dec 28, 2021 | |
| 71335-1254-4 | 71335125404 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1254-4)Marketed from Jul 24, 2019 | |
| 71335-1254-5 | 71335125405 | 50 TABLET, FILM COATED in 1 BOTTLE (71335-1254-5)Marketed from Dec 28, 2021 | |
| 71335-1254-6 | 71335125406 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1254-6)Marketed from Jun 27, 2019 | |
| 71335-1254-7 | 71335125407 | 45 TABLET, FILM COATED in 1 BOTTLE (71335-1254-7)Marketed from Dec 28, 2021 | |
| 71335-1254-8 | 71335125408 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-1254-8)Marketed from Dec 28, 2021 | |
| 71335-1254-9 | 71335125409 | 56 TABLET, FILM COATED in 1 BOTTLE (71335-1254-9)Marketed from Dec 28, 2021 |
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, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 089399
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-1254_0f092467-7f36-1cb2-e063-6394a90a88a2SPL ID 0f092467-7f36-1cb2-e063-6394a90a88a2SPL set ID 541ba74a-babb-4731-a5ef-fe7c18992c0bRxCUI 856834UNII 26LUD4JO9K
- 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
N471335125400followed by a unit qualifier and the quantityPackage 71335-1254-00. 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 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.
Other NDCs under ANDA 089399
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 Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-703 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1256 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-710 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-711 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 57664-688 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 57664-687 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 57664-689 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 57664-690 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 150 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 57664-691 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-750 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 75 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 57664-692 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-751 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-752 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 50 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-795 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 10 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-793 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 25 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-794 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 75 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-796 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 100 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-797 |
| Amitriptyline Hydrochloride | Amitriptyline hydrochloride 150 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-798 |