Home NDC 0049-4900 Zoloft
Product NDC 0049-4900
11-digit product format 000494900
Labeler code 0049
Product ID 0049-4900_842b5b3f-e0f0-4a16-bb47-2750a605452c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sertraline hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ROERIG
Application NDA019839
Marketing category NDA
Marketing start 1992-02-11
Marketing end 2026-06-30
Substance SERTRALINE HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019839-001 ZOLOFT SERTRALINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 N019839-002 ZOLOFT SERTRALINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 N019839-003 ZOLOFT SERTRALINE HYDROCHLORIDE EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 N019839-004 ZOLOFT SERTRALINE HYDROCHLORIDE EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 N019839-005 ZOLOFT SERTRALINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 6 · 210 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019839-001 ZOLOFT EQ 50MG BASE TABLET / ORAL AB RLD 1991-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019839-002 ZOLOFT EQ 100MG BASE TABLET / ORAL AB RLD, RS 1991-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019839-003 ZOLOFT EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019839-004 ZOLOFT EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1991-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019839-005 ZOLOFT EQ 25MG BASE TABLET / ORAL AB RLD 1996-03-06 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0049-4900-30 Zoloft 30 in 1 BOTTLE TABLET, FILM COATED 30 68 0049-4900-41 Zoloft 1 in 1 BLISTER PACK TABLET, FILM COATED 1 68 0049-4900-41 Zoloft 100 in 1 CARTON TABLET, FILM COATED 100 68 0049-4900-66 Zoloft 100 in 1 BOTTLE TABLET, FILM COATED 100 68 0049-4900-73 Zoloft 500 in 1 BOTTLE TABLET, FILM COATED 500 68 0049-4900-94 Zoloft 5000 in 1 BOTTLE TABLET, FILM COATED 5000 68
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SERTRALINE HYDROCHLORIDE ACTIVE INGREDIENT UTI8907Y6X ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 SERTRALINE ACTIVE MOIETY QUC7NX6WMB ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 ALCOHOL INACTIVE INGREDIENT 3K9958V90M ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 MENTHOL, UNSPECIFIED FORM INACTIVE INGREDIENT L7T10EIP3A ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 32 sertraline hydrochloride ACTIVE INGREDIENT UTI8907Y6X ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 sertraline ACTIVE MOIETY QUC7NX6WMB ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 aluminum oxide INACTIVE INGREDIENT LMI26O6933 ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 dibasic calcium phosphate dihydrate INACTIVE INGREDIENT O7TSZ97GEP ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 hydroxypropyl cellulose INACTIVE INGREDIENT RFW2ET671P ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 SERTRALINE HYDROCHLORIDE ACTIVE INGREDIENT UTI8907Y6X ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 sertraline ACTIVE MOIETY QUC7NX6WMB ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 aluminum oxide INACTIVE INGREDIENT LMI26O6933 ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 dibasic calcium phosphate dihydrate INACTIVE INGREDIENT O7TSZ97GEP ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 hydroxypropyl cellulose INACTIVE INGREDIENT RFW2ET671P ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 polyethylene glycol INACTIVE INGREDIENT 3WJQ0SDW1A ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0049-4900 ZOLOFT (SERTRALINE HYDROCHLORIDE) TABLET, FILM COATED ZOLOFT (SERTRALINE HYDROCHLORIDE) SOLUTION, CONCENTRATE [ROERIG] 66 Current NDC, Legacy NDC, 6 package rows 20241206_fe9e8b7d-61ea-409d-84aa-3ebd79a046b5.zip
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Zoloft SERTRALINE HYDROCHLORIDE Viatris Specialty LLC fda754f6-d0f3-4dce-a17a-927d64f912f7 2023-08-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019839 application number: NDA019839
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0049-4900-30 00049490030 30 TABLET, FILM COATED in 1 BOTTLE (0049-4900-30) 1992-02-11 2026-06-30 No No Current 0049-4900-41 00049490041 100 BLISTER PACK in 1 CARTON (0049-4900-41) / 1 TABLET, FILM COATED in 1 BLISTER PACK 100 blister pack 1992-02-11 2026-06-30 No No Current 0049-4900-66 00049490066 100 TABLET, FILM COATED in 1 BOTTLE (0049-4900-66) 1992-02-11 0000-00-00 No No Current 0049-4900-73 00049490073 500 TABLET, FILM COATED in 1 BOTTLE (0049-4900-73) 1992-02-11 0000-00-00 No No Current 0049-4900-94 00049490094 5000 TABLET, FILM COATED in 1 BOTTLE (0049-4900-94) 1992-02-11 0000-00-00 No No Current