Sertraline Hydrochloride
- Product NDC
- 52959-872
- 11-digit product format
- 529590872
- Labeler code
- 52959
- Product ID
- 52959-872_a62fcc0d-ac44-43dd-b293-8e0204d7f882
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sertraline Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- H.J. Harkins Company Inc.
- Application
- ANDA077397
- Marketing category
- ANDA
- Marketing start
- 2007-12-18
- Marketing end
- 0000-00-00
- Substance
- SERTRALINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4ac594ea-ad8b-47fd-9b52-bbd98301675e | Product name | 1 | 20220317 |
| 255fa467-900b-5557-4215-6823352d1150 | Product name | 2 | 20211028 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52959-872-30 | 2019-11-13 | C162847 | 48780-1 | 97449f38-cf14-f6ea-e053-dbdaa90aa703 | Sertraline Hydrochloride Tablets 25 mg, 50 mg and 100 mg |
| 52959-872-60 | 2019-11-13 | C162847 | 48780-1 | 97449f38-cf14-f6ea-e053-dbdaa90aa703 | Sertraline Hydrochloride Tablets 25 mg, 50 mg and 100 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52959-872-30 | Sertraline Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | 3 | |
| 52959-872-60 | Sertraline Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52959-872-30 | EA - Each | 52959-872 | 4850ac9b-380a-41fb-b558-30c67b14e028 | 1 | 2012-07-24 |
| 52959-872-60 | EA - Each | 52959-872 | 56445a8b-6fb1-49f8-967c-cad056bdc160 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| SERTRALINE HYDROCHLORIDE | ACTIVE INGREDIENT | UTI8907Y6X | SERTRALINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.] | 3 | |
| SERTRALINE | ACTIVE MOIETY | QUC7NX6WMB | SERTRALINE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.] | 3 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312938 | sertraline HCl 100 MG Oral Tablet | PSN | 5365e9a7-ad09-4a85-95a1-a86f40c890a5 | 3 |
| 312940 | sertraline HCl 25 MG Oral Tablet | PSN | 5365e9a7-ad09-4a85-95a1-a86f40c890a5 | 3 |
| 312941 | sertraline HCl 50 MG Oral Tablet | PSN | 5365e9a7-ad09-4a85-95a1-a86f40c890a5 | 3 |
| 312938 | sertraline 100 MG Oral Tablet | SCD | 5365e9a7-ad09-4a85-95a1-a86f40c890a5 | 3 |
| 312940 | sertraline 25 MG Oral Tablet | SCD | 5365e9a7-ad09-4a85-95a1-a86f40c890a5 | 3 |
| 312941 | sertraline 50 MG Oral Tablet | SCD | 5365e9a7-ad09-4a85-95a1-a86f40c890a5 | 3 |
| 312938 | sertraline (as sertraline HCl) 100 MG Oral Tablet | SY | 5365e9a7-ad09-4a85-95a1-a86f40c890a5 | 3 |
| 312940 | sertraline (as sertraline HCl) 25 MG Oral Tablet | SY | 5365e9a7-ad09-4a85-95a1-a86f40c890a5 | 3 |
| 312941 | sertraline (as sertraline HCl) 50 MG Oral Tablet | SY | 5365e9a7-ad09-4a85-95a1-a86f40c890a5 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 52959-872-30 | 52959087230 | 30 in 1 BOTTLE | Historical |
| 52959-872-60 | 52959087260 | 60 in 1 BOTTLE | Historical |