Prescription drug · ANDA
Doxepin Hydrochloride NDC 71335-1941
Doxepin hydrochloride 25 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1941-1 | 71335194101 | 30 CAPSULE in 1 BOTTLE (71335-1941-1)Marketed from Dec 29, 2021 | |
| 71335-1941-2 | 71335194102 | 60 CAPSULE in 1 BOTTLE (71335-1941-2)Marketed from Dec 29, 2021 | |
| 71335-1941-3 | 71335194103 | 28 CAPSULE in 1 BOTTLE (71335-1941-3)Marketed from Dec 29, 2021 | |
| 71335-1941-4 | 71335194104 | 18 CAPSULE in 1 BOTTLE (71335-1941-4)Marketed from Dec 29, 2021 | |
| 71335-1941-5 | 71335194105 | 90 CAPSULE in 1 BOTTLE (71335-1941-5)Marketed from Aug 31, 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)
- Doxepin Hydrochloride
- Generic name (nonproprietary)
- doxepin hydrochloride
- Active ingredients
- Doxepin hydrochloride — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213474
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-1941_e5eab47e-ac23-4fed-8ed1-ae046daa85e9SPL ID e5eab47e-ac23-4fed-8ed1-ae046daa85e9SPL set ID ec948b3d-4853-41bb-9f01-faf28fe369e5RxCUI 1000070UNII 3U9A0FE9N5
- 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
N471335194101followed by a unit qualifier and the quantityPackage 71335-1941-01. 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)
Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1. Psychoneurotic patients with depression and/or anxiety. 2. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). 3. Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). 4. Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to Doxepin Hydrochloride Capsules, USP include anxiety, tension, depression, somatic symptoms and…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213474
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 |
|---|---|---|---|---|
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Contract Pharmacal Corp. | 10267-5059 |
| Doxepin Hydrochloride | Doxepin hydrochloride 75 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2228 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Contract Pharmacal Corp. | 10267-5060 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2408 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Contract Pharmacal Corp. | 10267-5061 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-334 |
| Doxepin Hydrochloride | Doxepin hydrochloride 75 mg/1 | CapsuleOral | Contract Pharmacal Corp. | 10267-5062 |
| Doxepin Hydrochloride | Doxepin hydrochloride 100 mg/1 | CapsuleOral | Contract Pharmacal Corp. | 10267-5063 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Florida Pharmaceutical Products, LLC | 71921-164 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Florida Pharmaceutical Products, LLC | 71921-162 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Florida Pharmaceutical Products, LLC | 71921-163 |
| Doxepin Hydrochloride | Doxepin hydrochloride 75 mg/1 | CapsuleOral | Florida Pharmaceutical Products, LLC | 71921-165 |
| Doxepin Hydrochloride | Doxepin hydrochloride 100 mg/1 | CapsuleOral | Florida Pharmaceutical Products, LLC | 71921-166 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2227 |