Amitriptyline Hydrochloride

Product NDC
0603-2212
11-digit product format
006032212
Labeler code
0603
Product ID
0603-2212_a7995882-a206-47a1-af3b-c8c047aec191
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA040218
Marketing category
ANDA
Marketing start
1997-09-11
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e5006e90-7f2e-4341-bcdb-f83027a8fc39Product name620240611
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-2212-02EA - Each0603-2212adcbb7fa-5495-4f50-8c0b-0d8de82917b312012-07-24
0603-2212-16EA - Each0603-22125081a0a3-db97-4a0a-b4fb-b6e75c40017912012-07-24
0603-2212-21EA - Each0603-2212da04539b-4811-4036-9532-4097b256148312012-07-24
0603-2212-32EA - Each0603-221223d7dbbf-2c40-42a6-9dda-7a44bf2d86ca12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]13
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]13
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]13
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]13
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]13
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]13
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]13
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]13
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]13
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]2
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]2
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX]2
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MEDVANTX, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856783amitriptyline HCl 10 MG Oral TabletPSN5f95829b-4040-49a8-bac4-a845c227c81a13
856783amitriptyline hydrochloride 10 MG Oral TabletSCD5f95829b-4040-49a8-bac4-a845c227c81a13
856783amitriptyline HCl 10 MG Oral TabletPSN50d7ed6a-ef44-593d-e054-00144ff8d46c4
856783amitriptyline hydrochloride 10 MG Oral TabletSCD50d7ed6a-ef44-593d-e054-00144ff8d46c4
856783amitriptyline HCl 10 MG Oral TabletPSN26075684-acec-4423-aefc-0ccbcc1ff2972
856783amitriptyline HCl 10 MG Oral TabletPSN5e0f1cb3-5c78-4848-9a35-7ea20cc8ad7d2
856834amitriptyline HCl 25 MG Oral TabletPSN26075684-acec-4423-aefc-0ccbcc1ff2972
856845amitriptyline HCl 50 MG Oral TabletPSN26075684-acec-4423-aefc-0ccbcc1ff2972
856783amitriptyline hydrochloride 10 MG Oral TabletSCD26075684-acec-4423-aefc-0ccbcc1ff2972
856783amitriptyline hydrochloride 10 MG Oral TabletSCD5e0f1cb3-5c78-4848-9a35-7ea20cc8ad7d2
856834amitriptyline hydrochloride 25 MG Oral TabletSCD26075684-acec-4423-aefc-0ccbcc1ff2972
856845amitriptyline hydrochloride 50 MG Oral TabletSCD26075684-acec-4423-aefc-0ccbcc1ff2972
856783amitriptyline HCl 10 MG Oral TabletPSNff5aa574-0ef8-482f-815f-32357a9597071
856783amitriptyline HCl 10 MG Oral TabletPSN348f7c87-ec55-4917-8cf6-4a3b749a72c11
856762amitriptyline HCl 100 MG Oral TabletPSN348f7c87-ec55-4917-8cf6-4a3b749a72c11
856773amitriptyline HCl 150 MG Oral TabletPSN348f7c87-ec55-4917-8cf6-4a3b749a72c11
856834amitriptyline HCl 25 MG Oral TabletPSN348f7c87-ec55-4917-8cf6-4a3b749a72c11
856845amitriptyline HCl 50 MG Oral TabletPSN348f7c87-ec55-4917-8cf6-4a3b749a72c11
856853amitriptyline HCl 75 MG Oral TabletPSN348f7c87-ec55-4917-8cf6-4a3b749a72c11
856783amitriptyline hydrochloride 10 MG Oral TabletSCD348f7c87-ec55-4917-8cf6-4a3b749a72c11
856783amitriptyline hydrochloride 10 MG Oral TabletSCDff5aa574-0ef8-482f-815f-32357a9597071
856762amitriptyline hydrochloride 100 MG Oral TabletSCD348f7c87-ec55-4917-8cf6-4a3b749a72c11
856773amitriptyline hydrochloride 150 MG Oral TabletSCD348f7c87-ec55-4917-8cf6-4a3b749a72c11
856834amitriptyline hydrochloride 25 MG Oral TabletSCD348f7c87-ec55-4917-8cf6-4a3b749a72c11
856845amitriptyline hydrochloride 50 MG Oral TabletSCD348f7c87-ec55-4917-8cf6-4a3b749a72c11
856853amitriptyline hydrochloride 75 MG Oral TabletSCD348f7c87-ec55-4917-8cf6-4a3b749a72c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0603-2212-2100603221221100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-2212-21) 1997-09-110000-00-00NoNoCurrent
0603-2212-32006032212321000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-2212-32) 1997-09-110000-00-00NoNoCurrent