Trazodone Hydrochloride
- Product NDC
- 33261-107
- 11-digit product format
- 332610107
- Labeler code
- 33261
- Product ID
- 33261-107_ed1631ee-9ac0-4936-9749-e6be6ef1aa44
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Trazodone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA071523
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- Marketing end
- 0000-00-00
- Substance
- TRAZODONE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ac7a3d9b-58c0-4ffc-a3eb-ed863453525e | Product name | 1 | 20250730 |
| b2f15d64-48ea-ba98-af5c-91f410667b31 | Product name | 5 | 20250314 |
| d8e7f61b-4ab5-0dbe-2706-4e11b6079b87 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 33261-107-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-171f-f424-e053-dadaa90a57ce | TRAZODONE HYDROCHLORIDE TABLETS, USP |
| 33261-107-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-171f-f424-e053-dadaa90a57ce | TRAZODONE HYDROCHLORIDE TABLETS, USP |
| 33261-107-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-171f-f424-e053-dadaa90a57ce | TRAZODONE HYDROCHLORIDE TABLETS, USP |
| 33261-107-28 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-171f-f424-e053-dadaa90a57ce | TRAZODONE HYDROCHLORIDE TABLETS, USP |
| 33261-107-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-171f-f424-e053-dadaa90a57ce | TRAZODONE HYDROCHLORIDE TABLETS, USP |
| 33261-107-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-171f-f424-e053-dadaa90a57ce | TRAZODONE HYDROCHLORIDE TABLETS, USP |
| 33261-107-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-171f-f424-e053-dadaa90a57ce | TRAZODONE HYDROCHLORIDE TABLETS, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33261-107-02 | Trazodone Hydrochloride | 120 in 1 BOTTLE | TABLET | 120 | 1 | |
| 33261-107-10 | Trazodone Hydrochloride | 10 in 1 BOTTLE | TABLET | 10 | 1 | |
| 33261-107-20 | Trazodone Hydrochloride | 20 in 1 BOTTLE | TABLET | 20 | 1 | |
| 33261-107-28 | Trazodone Hydrochloride | 28 in 1 BOTTLE | TABLET | 28 | 1 | |
| 33261-107-30 | Trazodone Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 1 | |
| 33261-107-60 | Trazodone Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | 1 | |
| 33261-107-90 | Trazodone Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 33261-107-20 | EA - Each | 33261-107 | 5eea37c1-faec-4481-9039-ac8980234fef | 1 | 2015-10-02 |
| 33261-107-28 | EA - Each | 33261-107 | c15ca11e-b35c-49c0-a83b-781af0b77429 | 1 | 2015-10-02 |
| 33261-107-30 | EA - Each | 33261-107 | 9134a495-db28-4607-a80f-ab4888b71e77 | 1 | 2015-10-02 |
| 33261-107-60 | EA - Each | 33261-107 | b3f096a6-1b3c-4387-a5c5-27022d39e87e | 1 | 2015-10-02 |
| 33261-107-90 | EA - Each | 33261-107 | 75348ae1-0ebc-42c8-ba97-58e7b9bfe846 | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TRAZODONE HYDROCHLORIDE | ACTIVE INGREDIENT | 6E8ZO8LRNM | TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| TRAZODONE | ACTIVE MOIETY | YBK48BXK30 | TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | TRAZODONE HYDROCHLORIDE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 856373 | traZODone HCl 100 MG Oral Tablet | PSN | 3f8d7e17-b580-4340-bd8f-e76f8ba00422 | 1 |
| 856364 | traZODone HCl 150 MG Oral Tablet | PSN | 3f8d7e17-b580-4340-bd8f-e76f8ba00422 | 1 |
| 856377 | traZODone HCl 50 MG Oral Tablet | PSN | 3f8d7e17-b580-4340-bd8f-e76f8ba00422 | 1 |
| 856373 | trazodone hydrochloride 100 MG Oral Tablet | SCD | 3f8d7e17-b580-4340-bd8f-e76f8ba00422 | 1 |
| 856364 | trazodone hydrochloride 150 MG Oral Tablet | SCD | 3f8d7e17-b580-4340-bd8f-e76f8ba00422 | 1 |
| 856377 | trazodone hydrochloride 50 MG Oral Tablet | SCD | 3f8d7e17-b580-4340-bd8f-e76f8ba00422 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 33261-107-02 | 33261010702 | 120 in 1 BOTTLE | Historical |
| 33261-107-10 | 33261010710 | 10 in 1 BOTTLE | Historical |
| 33261-107-20 | 33261010720 | 20 in 1 BOTTLE | Historical |
| 33261-107-28 | 33261010728 | 28 in 1 BOTTLE | Historical |
| 33261-107-30 | 33261010730 | 30 in 1 BOTTLE | Historical |
| 33261-107-60 | 33261010760 | 60 in 1 BOTTLE | Historical |
| 33261-107-90 | 33261010790 | 90 in 1 BOTTLE | Historical |