Home NDC 64980-159-01 Protriptyline Hydrochloride
Product NDC 64980-159
Requested package NDC 64980-159-01
11-digit product format 649800159
Labeler code 64980
Product ID 64980-159_995c0f12-2125-da56-e053-2995a90a8dfe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Protriptyline Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rising Pharmaceuticals, Inc
Application ANDA090462
Marketing category ANDA
Marketing start 2010-06-11
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 2020-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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.
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 [RISING PHARMACEUTICALS, INC] 5 PROTRIPTYLINE ACTIVE MOIETY 4NDU154T12 PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMACEUTICALS, INC] 5 ANHYDROUS DIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT L11K75P92J PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMACEUTICALS, INC] 5 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMACEUTICALS, INC] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMACEUTICALS, INC] 5 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMACEUTICALS, INC] 5 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMACEUTICALS, INC] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMACEUTICALS, INC] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMACEUTICALS, INC] 5 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMACEUTICALS, INC] 5 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMACEUTICALS, INC] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMACEUTICALS, INC] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PROTRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [RISING PHARMACEUTICALS, INC] 5
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 64980-159-01 64980015901 100 TABLET, FILM COATED in 1 BOTTLE (64980-159-01) 2010-06-11 0000-00-00 No No Current