Home NDC 35356-759 Amitriptyline Hydrochloride
Product NDC 35356-759
11-digit product format 353560759
Labeler code 35356
Product ID 35356-759_410c5db5-394f-4cbe-89bc-168f207a9d42
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amitriptyline Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lake Erie Medical DBA Quality Care Products LLC
Application ANDA040218
Marketing category ANDA
Marketing start 1997-09-11
Marketing end 0000-00-00
Substance AMITRIPTYLINE HYDROCHLORIDE
Active strength 75 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 2019-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040218-001 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL 1997-09-11 A040218-002 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL 1997-09-11 A040218-003 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-09-11 A040218-004 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL 1997-09-11 A040218-005 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-09-11 A040218-006 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL 1997-09-11
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 7 · 258 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 A040218-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL 1997-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040218-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL 1997-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040218-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040218-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL 1997-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040218-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040218-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL 1997-09-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040218-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL 1997-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040218-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL 1997-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040218-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040218-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL 1997-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040218-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040218-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL 1997-09-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040218-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL 1997-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040218-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL 1997-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040218-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040218-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL 1997-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040218-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040218-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL 1997-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040218-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL 1997-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040218-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL 1997-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040218-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040218-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL 1997-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040218-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040218-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL 1997-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040218-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL 1997-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040218-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL 1997-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040218-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040218-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL 1997-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040218-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040218-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL 1997-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040218-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL 1997-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040218-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL 1997-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040218-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040218-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL 1997-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040218-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040218-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL 1997-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040218-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL 1997-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040218-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL 1997-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040218-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040218-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL 1997-09-11 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.