Home NDC 42806-097 Protriptyline Hydrochloride
Product NDC 42806-097
11-digit product format 428060097
Labeler code 42806
Product ID 42806-097_e68d74c7-1d6a-4453-bb46-0047047b7527
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Protriptyline Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Epic Pharma, LLC
Application ANDA202220
Marketing category ANDA
Marketing start 2013-01-09
Substance PROTRIPTYLINE HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 86 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 2026-09-14 22:38:34 2026-08 A202220-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2012-11-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202220-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB RS 2012-11-19 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Protriptyline Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROTRIPTYLINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 44665V00O8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 905168 Internal RxNorm lookup 905172 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42806-097-01 Protriptyline Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 10 42806-097-10 Protriptyline Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 10 42806-097-30 Protriptyline Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 10
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 [EPIC PHARMA, LLC] 5 PROTRIPTYLINE ACTIVE MOIETY 4NDU154T12 PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 5 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 5 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 5 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 5 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 5 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 5 STARCH, POTATO INACTIVE INGREDIENT 8I089SAH3T PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 5 STARCH, TAPIOCA INACTIVE INGREDIENT 24SC3U704I PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 5 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-097 PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [EPIC PHARMA, LLC] 10 Current NDC, Legacy NDC, 3 package rows 20231221_c6c7c39e-e510-4f4a-bf7a-926f0e075d3a.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 42806-097-01 42806009701 100 TABLET, FILM COATED in 1 BOTTLE (42806-097-01) 2013-01-09 0000-00-00 No No Current 42806-097-10 42806009710 1000 TABLET, FILM COATED in 1 BOTTLE (42806-097-10) 2013-01-09 0000-00-00 No No Current 42806-097-30 42806009730 30 TABLET, FILM COATED in 1 BOTTLE (42806-097-30) 2020-07-10 0000-00-00 No No Current