Home NDC 43353-306-53 Amitriptyline Hydrochloride
Product NDC 43353-306
Requested package NDC 43353-306-53
11-digit product format 433530306
Labeler code 43353
Product ID 43353-306_07634e8c-9803-4f7f-96fe-e68dde500f6d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amitriptyline Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA085969
Marketing category ANDA
Marketing start 1977-11-21
Marketing end 0000-00-00
Substance AMITRIPTYLINE 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 43353-306 43353-306-53 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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 A085969-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB Approved before 1982 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 A085969-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A085969-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A085969-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 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.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 43353-306-30 2024-04-23 Amitriptyline Hydrochloride Tablets, USP 43353-306-53 2024-04-23 Amitriptyline Hydrochloride Tablets, USP 43353-306-60 2024-04-23 Amitriptyline Hydrochloride Tablets, USP 43353-306-80 2024-04-23 Amitriptyline Hydrochloride Tablets, USP 43353-306-30 2023-01-30 Amitriptyline Hydrochloride Tablets, USP 43353-306-53 2023-01-30 Amitriptyline Hydrochloride Tablets, USP 43353-306-60 2023-01-30 Amitriptyline Hydrochloride Tablets, USP 43353-306-80 2023-01-30 Amitriptyline Hydrochloride Tablets, USP
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-306 AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 3 Legacy NDC 20240424_19b236d3-eebc-42eb-b66e-141cb5fe91c2.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 43353-306-53 43353030653 60 TABLET, FILM COATED in 1 BOTTLE (43353-306-53) 2017-06-19 0000-00-00 No No Current