Prescription drug · ANDA
Doxepin Hydrochloride NDC 0378-5375
Doxepin hydrochloride 75 mg/1 · Capsule · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0378-5375-01 | 00378537501 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-5375-01)Marketed from May 13, 1986 | |
| 0378-5375-10 | 00378537510 | 1000 CAPSULE in 1 BOTTLE, PLASTIC (0378-5375-10)Marketed from May 13, 1986 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Doxepin Hydrochloride
- Generic name (nonproprietary)
- doxepin hydrochloride
- Active ingredients
- Doxepin hydrochloride — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070791
- Marketing start
- Listing expires
- Identifiers
- Product ID 0378-5375_335104fb-31eb-4460-b3ab-19869176b320SPL ID 335104fb-31eb-4460-b3ab-19869176b320SPL set ID 1533343b-f1ed-4c3a-bb36-23a748452b05RxCUI 1000048, 1000058, 1000070, 1000076, 1000097UNII 3U9A0FE9N5UPC 0303785375012, 0303786410019, 0303784250013, 0303781049016, 0303783125015
- 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
N400378537501followed by a unit qualifier and the quantityPackage 00378-5375-01. 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 are indicated for the treatment of major depressive disorder (MDD) in adults. Doxepin hydrochloride capsules are a tricyclic antidepressant (TCA) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 070791
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 100 mg/1 | CapsuleOral | Mylan Institutional Inc. | 51079-651 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-4250 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-5033 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-329 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-331 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-072 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 55289-370 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-1049 |
| Doxepin Hydrochloride | Doxepin hydrochloride 100 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-6410 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-3125 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-035 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-036 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-037 |
| Doxepin Hydrochloride | Doxepin hydrochloride 100 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-038 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Mylan Institutional Inc. | 51079-437 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Mylan Institutional Inc. | 51079-436 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Mylan Institutional Inc. | 51079-438 |