Home NDC 49999-205 Amitriptyline Hydrochloride
Product NDC 49999-205
11-digit product format 499990205
Labeler code 49999
Product ID 49999-205_d3e801b0-8833-4869-bb10-c82aa7620312
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amitriptyline Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Application ANDA085969
Marketing category ANDA
Marketing start 2011-10-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMITRIPTYLINE HYDROCHLORIDE ACTIVE INGREDIENT 26LUD4JO9K AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3124 AMITRIPTYLINE ACTIVE MOIETY 1806D8D52K AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3124 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3124 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3124 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3124 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3124 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3124 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3124 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3124 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3124 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3124 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3124 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3124 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC] 3124
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49999-205-00 49999020500 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49999-205-00) 2011-10-31 0000-00-00 No No Current 49999-205-30 49999020530 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49999-205-30) 2011-10-31 0000-00-00 No No Current