Home NDC 63629-6630 Amitriptyline Hydrochloride
Product NDC 63629-6630
11-digit product format 636296630
Labeler code 63629
Product ID 63629-6630_24e012a6-a182-46e1-8fcf-ecffb5b9fb7c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amitriptyline Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA040218
Marketing category ANDA
Marketing start 1997-09-11
Marketing end 0000-00-00
Substance AMITRIPTYLINE HYDROCHLORIDE
Active strength 25 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.