Home NDC 67296-0388-2 Amitriptyline Hydrochloride
Product NDC 67296-0388
Requested package NDC 67296-0388-2
11-digit product format 672960388
Labeler code 67296
Product ID 67296-0388_d5fbf853-5c48-2ecf-e053-2a95a90ab67f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amitriptyline Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler RedPharm Drug, Inc.
Application ANDA085966
Marketing category ANDA
Marketing start 1977-11-21
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 2023-12-31
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 · 5 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67296-0388-1 Amitriptyline Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 9 67296-0388-2 Amitriptyline Hydrochloride 42 in 1 BOTTLE TABLET, FILM COATED 42 9 67296-0388-3 Amitriptyline Hydrochloride 15 in 1 BOTTLE TABLET, FILM COATED 15 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67296-0388 AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REDPHARM DRUG, INC.] 9 Legacy NDC, 3 package rows 20240711_41963d1c-8dd8-08ef-e054-00144ff8d46c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 67296-0388-2 67296038802 42 TABLET, FILM COATED in 1 BOTTLE (67296-0388-2) 1977-11-21 0000-00-00 No No Current