Home NDC 61919-011 AMITRIPTYLINE HYDROCHLORIDE
Product NDC 61919-011
11-digit product format 619190011
Labeler code 61919
Product ID 61919-011_bc07fdcc-a859-43e2-ad63-f6c20d811c51
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name AMITRIPTYLINE HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler DIRECT RX
Application ANDA040218
Marketing category ANDA
Marketing start 2014-01-01
Marketing end 0000-00-00
Substance AMITRIPTYLINE HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag E
Listing certified through 2017-12-31
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 2 · 88 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A040218-001 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL 1997-09-11 A040218-002 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL 1997-09-11 A040218-003 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-09-11 A040218-004 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL 1997-09-11 A040218-005 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-09-11 A040218-006 AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL 1997-09-11
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 7 · 258 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 A040218-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL 1997-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040218-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL 1997-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040218-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040218-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL 1997-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040218-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A040218-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL 1997-09-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A040218-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL 1997-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040218-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL 1997-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040218-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040218-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL 1997-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040218-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-09-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040218-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL 1997-09-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040218-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL 1997-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040218-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL 1997-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040218-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040218-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL 1997-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040218-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-09-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040218-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL 1997-09-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040218-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL 1997-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040218-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL 1997-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040218-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040218-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL 1997-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040218-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-09-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040218-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL 1997-09-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040218-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL 1997-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040218-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL 1997-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040218-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040218-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL 1997-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040218-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-09-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040218-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL 1997-09-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040218-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL 1997-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040218-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL 1997-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040218-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040218-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL 1997-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040218-005 AMITRIPTYLINE HYDROCHLORIDE 100MG TABLET / ORAL 1997-09-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040218-006 AMITRIPTYLINE HYDROCHLORIDE 150MG TABLET / ORAL 1997-09-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040218-001 AMITRIPTYLINE HYDROCHLORIDE 10MG TABLET / ORAL 1997-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040218-002 AMITRIPTYLINE HYDROCHLORIDE 25MG TABLET / ORAL 1997-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040218-003 AMITRIPTYLINE HYDROCHLORIDE 50MG TABLET / ORAL 1997-09-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040218-004 AMITRIPTYLINE HYDROCHLORIDE 75MG TABLET / ORAL 1997-09-11 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61919-011-30 AMITRIPTYLINE HYDROCHLORIDE 30 in 1 BOTTLE TABLET, FILM COATED 30 2 61919-011-60 AMITRIPTYLINE HYDROCHLORIDE 60 in 1 BOTTLE TABLET, FILM COATED 60 2 61919-011-90 AMITRIPTYLINE HYDROCHLORIDE 90 in 1 BOTTLE TABLET, FILM COATED 90 2
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 [DIRECT RX] 2 AMITRIPTYLINE ACTIVE MOIETY 1806D8D52K AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-011 AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [DIRECT RX] 2 Legacy NDC, 3 package rows 20151030_5e0f1cb3-5c78-4848-9a35-7ea20cc8ad7d.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 61919-011-30 61919001130 30 in 1 BOTTLE Historical 61919-011-60 61919001160 60 in 1 BOTTLE Historical 61919-011-90 61919001190 90 in 1 BOTTLE Historical