FDA.reportPublic FDA data

Amitriptyline Hydrochloride

Product NDC
71205-823
11-digit product format
712050823
Labeler code
71205
Product ID
71205-823_0221f0ce-11e7-171c-e063-6294a90af405
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amitriptyline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA214548
Marketing category
ANDA
Marketing start
2021-05-26
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
Rxcui856845

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-823-30Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
71205-823-60Amitriptyline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
71205-823-90Amitriptyline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-823-30EA - Each71205-8234e51921e-625d-4a25-9d4d-67e310d311b912023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-823AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, 3 package rows20230805_e42225f5-44bd-451e-98a1-aa3877457733.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
856845amitriptyline HCl 50 MG Oral TabletPSNe42225f5-44bd-451e-98a1-aa38774577332
856845amitriptyline hydrochloride 50 MG Oral TabletSCDe42225f5-44bd-451e-98a1-aa38774577332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-823-307120508233030 TABLET, FILM COATED in 1 BOTTLE (71205-823-30) 2023-08-01NoNoHistorical
71205-823-607120508236060 TABLET, FILM COATED in 1 BOTTLE (71205-823-60) 2023-08-01NoNoHistorical
71205-823-907120508239090 TABLET, FILM COATED in 1 BOTTLE (71205-823-90) 2023-08-01NoNoHistorical