NDC 16729-216-01 - SERTRALINE HYDROCHLORIDE
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 16729-216
- Requested NDC
- 16729-216-01
- Package NDCs from labels
- 16729-216-10, 16729-216-15, 16729-216-01, 16729-216-16, 16729-216-43
- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Effective date
- 2026-05-21
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| SERTRALINE HYDROCHLORIDE - PD-Rx Pharmaceuticals, Inc. | PD-Rx Pharmaceuticals, Inc. | 2026-05-21 | HUMAN PRESCRIPTION DRUG LABEL |
| SERTRALINE HYDROCHLORIDE - Accord Healthcare, Inc. | Intas Pharmaceuticals Ltd | Accord Healthcare, Inc. | Intas Pharmaceuticals Ltd | 2025-12-17 | HUMAN PRESCRIPTION DRUG LABEL |
| SERTRALINE HYDROCHLORIDE - QPharma, Inc. | Northwind Health Company, LLC | QPharma, Inc. | Northwind Health Company, LLC | 2025-12-15 | HUMAN PRESCRIPTION DRUG LABEL |
| SERTRALINE HYDROCHLORIDE - Quality Care Products, LLC | Quality Care Products, LLC | 2024-12-18 | HUMAN PRESCRIPTION DRUG LABEL |
| SERTRALINE HYDROCHLORIDE - REMEDYREPACK INC. | REMEDYREPACK INC. | 2024-09-24 | HUMAN PRESCRIPTION DRUG LABEL |
| SERTRALINE HYDROCHLORIDE - Preferred Pharmaceuticals Inc. | Preferred Pharmaceuticals Inc. | 2024-08-07 | HUMAN PRESCRIPTION DRUG LABEL |
| SERTRALINE HYDROCHLORIDE - Bryant Ranch Prepack | Bryant Ranch Prepack | 2024-04-03 | HUMAN PRESCRIPTION DRUG LABEL |
| SERTRALINE HYDROCHLORIDE - RPK Pharmaceuticals, Inc. | RPK Pharmaceuticals, Inc. | 2023-08-18 | HUMAN PRESCRIPTION DRUG LABEL |
| SERTRALINE HYDROCHLORIDE - RPK Pharmaceuticals, Inc. | RPK Pharmaceuticals, Inc. | 2023-08-18 | HUMAN PRESCRIPTION DRUG LABEL |
| Sertraline Hydrochloride - Direct Rx | Direct Rx | 2023-01-12 | HUMAN PRESCRIPTION DRUG LABEL |
| SERTRALINE HYDROCHLORIDE - St. Mary's Medical Park Pharmacy | St. Mary's Medical Park Pharmacy | 2022-12-20 | HUMAN PRESCRIPTION DRUG LABEL |
| SERTRALINE HYDROCHLORIDE - A-S Medication Solutions | A-S Medication Solutions | 2022-04-13 | HUMAN PRESCRIPTION DRUG LABEL |
| SERTRALINE HYDROCHLORIDE - NuCare Pharmaceuticals,Inc. | NuCare Pharmaceuticals,Inc. | 2021-08-06 | HUMAN PRESCRIPTION DRUG LABEL |
| SERTRALINE HYDROCHLORIDE - Unit Dose Services | Unit Dose Services | 2021-05-20 | HUMAN PRESCRIPTION DRUG LABEL |
| Sertraline Hydrochloride Tablets USP | NuCare Pharmaceuticals, Inc. | 2021-02-12 | HUMAN PRESCRIPTION DRUG LABEL |
| SERTRALINE HYDROCHLORIDE - Denton Pharma, Inc. DBA Northwind Pharmaceuticals | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 2021-01-25 | HUMAN PRESCRIPTION DRUG LABEL |
| Sertraline Hydrochloride - Direct_Rx | Direct_Rx | 2021-01-07 | HUMAN PRESCRIPTION DRUG LABEL |
| SERTRALINE HYDROCHLORIDE - Proficient Rx LP | Proficient Rx LP | 2019-11-01 | HUMAN PRESCRIPTION DRUG LABEL |
| SERTRALINE HYDROCHLORIDE - Preferred Pharmaceuticals Inc. | Preferred Pharmaceuticals Inc. | 2019-04-26 | HUMAN PRESCRIPTION DRUG LABEL |
| SERTRALINE HYDROCHLORIDE - DIRECT RX | DIRECT RX | 2018-03-14 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16729-216-01 | SERTRALINE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 19 | |
| 16729-216-10 | SERTRALINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 19 | |
| 16729-216-15 | SERTRALINE HYDROCHLORIDE | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 19 | |
| 16729-216-16 | SERTRALINE HYDROCHLORIDE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 19 | |
| 16729-216-43 | SERTRALINE HYDROCHLORIDE | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 100 | 19 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16729-216-15 | EA - Each | 16729-216 | 244cfc50-a442-4123-bebc-3fe1dd4c1f78 | 1 | 2017-03-06 |
| 16729-216-16 | EA - Each | 16729-216 | 03832b5b-daa3-4a2f-90be-0c1e4075fed3 | 1 | 2017-03-06 |
DailyMed Socrata Ingredients#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.