Home NDC 50383-960 Protriptyline hydrochloride
Product NDC 50383-960
11-digit product format 503830960
Labeler code 50383
Product ID 50383-960_df490f7b-6f10-48dc-9bd9-162746fd8f76
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Protriptyline hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Hi-Tech Pharmacal Co., Inc.
Application ANDA202220
Marketing category ANDA
Marketing start 2013-10-28
Marketing end 0000-00-00
Substance PROTRIPTYLINE HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50383-960-10 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50383-960-10 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50383-960-10 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50383-960-10 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50383-960-10 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50383-960-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50383-960-10 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50383-960-10 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50383-960-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50383-960-10 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50383-960-10 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50383-960-10 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202220-001 PROTRIPTYLINE HYDROCHLORIDE PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 A202220-002 PROTRIPTYLINE HYDROCHLORIDE PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2012-11-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 84 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 A202220-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202220-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2012-11-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202220-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202220-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2012-11-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202220-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202220-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2012-11-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202220-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202220-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2012-11-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202220-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202220-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-11-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202220-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202220-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-11-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202220-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202220-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-11-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202220-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202220-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-11-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202220-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202220-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-11-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202220-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202220-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-11-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202220-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202220-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-11-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202220-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202220-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-11-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202220-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202220-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-11-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202220-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202220-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-11-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202220-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202220-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-11-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202220-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202220-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-11-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202220-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202220-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-11-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202220-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202220-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-11-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202220-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202220-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-11-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202220-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202220-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2012-11-19 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PROTRIPTYLINE HYDROCHLORIDE ACTIVE INGREDIENT 44665V00O8 PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [HI-TECH PHARMACAL CO., INC.] 1 PROTRIPTYLINE ACTIVE MOIETY 4NDU154T12 PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [HI-TECH PHARMACAL CO., INC.] 1 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [HI-TECH PHARMACAL CO., INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [HI-TECH PHARMACAL CO., INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [HI-TECH PHARMACAL CO., INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [HI-TECH PHARMACAL CO., INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [HI-TECH PHARMACAL CO., INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [HI-TECH PHARMACAL CO., INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [HI-TECH PHARMACAL CO., INC.] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [HI-TECH PHARMACAL CO., INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [HI-TECH PHARMACAL CO., INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [HI-TECH PHARMACAL CO., INC.] 1 STARCH, POTATO INACTIVE INGREDIENT 8I089SAH3T PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [HI-TECH PHARMACAL CO., INC.] 1 STARCH, TAPIOCA INACTIVE INGREDIENT 24SC3U704I PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [HI-TECH PHARMACAL CO., INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [HI-TECH PHARMACAL CO., INC.] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [HI-TECH PHARMACAL CO., INC.] 1
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50383-960-10 50383096010 100 TABLET, FILM COATED in 1 BOTTLE (50383-960-10) 2013-10-28 0000-00-00 No No Current