Home NDC 42794-007 Protriptyline Hydrochloride
Product NDC 42794-007
11-digit product format 427940007
Labeler code 42794
Product ID 42794-007_f1f190da-554e-55cb-e053-2a95a90a2871
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Protriptyline Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sigmapharm Laboratories, LLC
Application ANDA090462
Marketing category ANDA
Marketing start 2020-03-02
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 1 .
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 A090462-001 PROTRIPTYLINE HYDROCHLORIDE PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-03 A090462-002 PROTRIPTYLINE HYDROCHLORIDE PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-03
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A090462-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090462-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090462-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090462-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090462-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090462-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090462-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090462-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090462-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090462-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090462-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090462-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090462-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090462-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090462-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090462-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090462-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090462-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090462-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090462-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090462-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090462-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090462-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090462-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090462-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090462-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090462-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090462-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090462-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090462-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090462-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090462-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090462-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090462-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090462-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090462-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090462-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-03 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090462-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090462-001 PROTRIPTYLINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-03 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A090462-002 PROTRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-03 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 42794-007-02 Protriptyline Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42794-007 PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SIGMAPHARM LABORATORIES, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20230111_a023e637-bee9-8c86-e053-2a95a90aa488.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 42794-007-02 42794000702 100 TABLET, FILM COATED in 1 BOTTLE (42794-007-02) 2020-03-02 0000-00-00 No No Current