Home NDC 72888-071-03 Amitriptyline Hydrochloride
Product NDC 72888-071
Requested package NDC 72888-071-03
11-digit product format 728880071
Labeler code 72888
Product ID 72888-071_451e8ad6-a78e-429b-e063-6394a90a2bdb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amitriptyline Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Advagen Pharma Ltd
Application ANDA215376
Marketing category ANDA
Marketing start 2023-05-01
Substance AMITRIPTYLINE HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215376-001 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-05-01 A215376-002 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-05-01 A215376-003 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2023-05-01 A215376-004 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2023-05-01 A215376-005 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2023-05-01 A215376-006 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2023-05-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
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.
Product history page 1 of 4 · 144 observed 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 2026-09-14 22:38:34 2026-08 A215376-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-05-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215376-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-05-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215376-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2023-05-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215376-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2023-05-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215376-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2023-05-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A215376-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2023-05-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A215376-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215376-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215376-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2023-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215376-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2023-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215376-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2023-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215376-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2023-05-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215376-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL BX 2023-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215376-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL BX 2023-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215376-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL BX 2023-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215376-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL BX 2023-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215376-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL BX 2023-05-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215376-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL BX 2023-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215376-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL BX 2023-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215376-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL BX 2023-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215376-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL BX 2023-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215376-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL BX 2023-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215376-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL BX 2023-05-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215376-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL BX 2023-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215376-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL BX 2023-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215376-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL BX 2023-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215376-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL BX 2023-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215376-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL BX 2023-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215376-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL BX 2023-05-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215376-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL BX 2023-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215376-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215376-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215376-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2023-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215376-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2023-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215376-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL AB 2023-05-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215376-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL AB 2023-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215376-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2023-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215376-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL AB 2023-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215376-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL AB 2023-05-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215376-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL AB 2023-05-01 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 144 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Amitriptyline Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMITRIPTYLINE HYDROCHLORIDE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 26LUD4JO9K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 856762 Internal RxNorm lookup 856773 Internal RxNorm lookup 856783 Internal RxNorm lookup 856834 Internal RxNorm lookup 856845 Internal RxNorm lookup 856853 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72888-071-01 Amitriptyline Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 4 72888-071-03 Amitriptyline Hydrochloride 300 in 1 BOTTLE TABLET, FILM COATED 300 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72888-071 AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ADVAGEN PHARMA LTD] 2 Current NDC, 2 package rows 20230706_651bd090-a420-4dd8-89b0-4cb766c144c2.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72888-071-03 72888007103 300 TABLET, FILM COATED in 1 BOTTLE (72888-071-03) 2023-05-01 No No Current