Home DailyMed d62a47e7-b89a-4e60-b915-0be907f8b56a 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 02:50:51 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 .
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.
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 A085966-001 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL AB RS, Approved before 1982 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 A085966-001 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL AB RS, Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A085966-001 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL AB RS, Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A085966-001 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL AB RS, Approved before 1982 ea99ee380514…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.