Home DailyMed eb5b6ec4-c19f-40ef-a1ca-e71dea02df7b National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:46:03 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 4 of 7 · 264 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 2019-12-13 00:20 UTC 2019-12 A040218-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1997-09-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040218-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1997-09-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040218-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1997-09-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040218-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL AB 1997-09-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040218-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL AB 1997-09-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A040218-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 1997-09-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040218-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1997-09-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040218-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1997-09-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040218-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1997-09-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040218-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL AB 1997-09-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040218-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL AB 1997-09-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A040218-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 1997-09-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040218-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1997-09-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040218-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1997-09-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040218-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1997-09-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040218-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL AB 1997-09-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040218-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL AB 1997-09-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A040218-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 1997-09-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040218-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1997-09-11 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040218-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1997-09-11 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040218-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1997-09-11 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040218-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL AB 1997-09-11 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040218-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL AB 1997-09-11 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040218-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 1997-09-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040218-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1997-09-11 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A040218-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1997-09-11 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A040218-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1997-09-11 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A040218-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL AB 1997-09-11 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A040218-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL AB 1997-09-11 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A040218-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 1997-09-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040218-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1997-09-11 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A040218-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1997-09-11 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A040218-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1997-09-11 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A040218-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL AB 1997-09-11 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A040218-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL AB 1997-09-11 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A040218-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 1997-09-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040218-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 1997-09-11 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A040218-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL AB 1997-09-11 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A040218-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL AB 1997-09-11 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A040218-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL AB 1997-09-11 c0c555d07b60…
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.