FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
16571-107
11-digit product format
165710107
Labeler code
16571
Product ID
16571-107_a83b8840-dd78-46f1-b952-893c30bf5bf9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA217411
Marketing category
ANDA
Marketing start
2023-06-10
Substance
AMITRIPTYLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amitriptyline Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMITRIPTYLINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii26LUD4JO9K
Rxcui856762, 856773, 856783, 856834, 856845, 856853

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e5006e90-7f2e-4341-bcdb-f83027a8fc39Product name620240611
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16571-107-01Amitriptyline Hydrochloride100 in 1 BOTTLETABLET1002
16571-107-10Amitriptyline Hydrochloride1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-107-01EA - Each16571-10768f353a2-9ae9-4d7c-a96b-cf6aa544e0a712023-08-08
16571-107-10EA - Each16571-1070f73ad63-1029-4b8f-ac76-0124aacd471e12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-107AMITRIPTYLINE HYDROCHLORIDE TABLET [RISING PHARMA HOLDINGS, INC.]2Current NDC, 2 package rows20250523_a219a68e-7ce5-4e9d-a0de-ec76960040f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856845amitriptyline HCl 50 MG Oral TabletPSN5dc3c2d7-60a2-4754-be33-1f9401c925a44
856845amitriptyline hydrochloride 50 MG Oral TabletSCD5dc3c2d7-60a2-4754-be33-1f9401c925a44
856783amitriptyline HCl 10 MG Oral TabletPSNa219a68e-7ce5-4e9d-a0de-ec76960040f62
856762amitriptyline HCl 100 MG Oral TabletPSNa219a68e-7ce5-4e9d-a0de-ec76960040f62
856773amitriptyline HCl 150 MG Oral TabletPSNa219a68e-7ce5-4e9d-a0de-ec76960040f62
856834amitriptyline HCl 25 MG Oral TabletPSN29ec1221-04d8-4b21-822e-2779fcaae62c2
856834amitriptyline HCl 25 MG Oral TabletPSNa219a68e-7ce5-4e9d-a0de-ec76960040f62
856845amitriptyline HCl 50 MG Oral TabletPSN29ec1221-04d8-4b21-822e-2779fcaae62c2
856845amitriptyline HCl 50 MG Oral TabletPSN54485767-d7c5-4927-ae52-08537a7a91e82
856845amitriptyline HCl 50 MG Oral TabletPSNa219a68e-7ce5-4e9d-a0de-ec76960040f62
856853amitriptyline HCl 75 MG Oral TabletPSNa219a68e-7ce5-4e9d-a0de-ec76960040f62
856783amitriptyline hydrochloride 10 MG Oral TabletSCDa219a68e-7ce5-4e9d-a0de-ec76960040f62
856762amitriptyline hydrochloride 100 MG Oral TabletSCDa219a68e-7ce5-4e9d-a0de-ec76960040f62
856773amitriptyline hydrochloride 150 MG Oral TabletSCDa219a68e-7ce5-4e9d-a0de-ec76960040f62
856834amitriptyline hydrochloride 25 MG Oral TabletSCDa219a68e-7ce5-4e9d-a0de-ec76960040f62
856834amitriptyline hydrochloride 25 MG Oral TabletSCD29ec1221-04d8-4b21-822e-2779fcaae62c2
856845amitriptyline hydrochloride 50 MG Oral TabletSCD54485767-d7c5-4927-ae52-08537a7a91e82
856845amitriptyline hydrochloride 50 MG Oral TabletSCDa219a68e-7ce5-4e9d-a0de-ec76960040f62
856845amitriptyline hydrochloride 50 MG Oral TabletSCD29ec1221-04d8-4b21-822e-2779fcaae62c2
856853amitriptyline hydrochloride 75 MG Oral TabletSCDa219a68e-7ce5-4e9d-a0de-ec76960040f62
856845amitriptyline HCl 50 MG Oral TabletPSN9110367c-4104-4836-8af3-649f86b0b3ea1
856845amitriptyline HCl 50 MG Oral TabletPSN20aff9dc-98a7-6061-e063-6394a90a2aab1
856845amitriptyline HCl 50 MG Oral TabletPSN3d9292dc-49a0-46f4-9980-3e8d57121d431
856845amitriptyline HCl 50 MG Oral TabletPSN35a7ce7d-4a29-e3f0-e063-6294a90ad66f1
856845amitriptyline hydrochloride 50 MG Oral TabletSCD9110367c-4104-4836-8af3-649f86b0b3ea1
856845amitriptyline hydrochloride 50 MG Oral TabletSCD3d9292dc-49a0-46f4-9980-3e8d57121d431
856845amitriptyline hydrochloride 50 MG Oral TabletSCD35a7ce7d-4a29-e3f0-e063-6294a90ad66f1
856845amitriptyline hydrochloride 50 MG Oral TabletSCD20aff9dc-98a7-6061-e063-6394a90a2aab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16571-107-0116571010701100 TABLET in 1 BOTTLE (16571-107-01) 100 tablet2023-06-10NoNoCurrent
16571-107-10165710107101000 TABLET in 1 BOTTLE (16571-107-10) 1000 tablet2023-06-10NoNoCurrent