Home NDC 33261-626 Amitriptyline Hydrochloride
Product NDC 33261-626
11-digit product format 332610626
Labeler code 33261
Product ID 33261-626_3b66c2f6-3d9f-4bc4-bad4-c6736f1d45e7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amitriptyline Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aidarex Pharmaceuticals LLC
Application ANDA040218
Marketing category ANDA
Marketing start 1997-09-11
Marketing end 0000-00-00
Substance AMITRIPTYLINE HYDROCHLORIDE
Active strength 100 mg/1
Pharmacologic classes Tricyclic Antidepressant [EPC]
NDC exclude flag No
Listing certified through 2019-12-31
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 · 84 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 33261-626-30 Amitriptyline Hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 1 33261-626-60 Amitriptyline Hydrochloride 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 1 33261-626-90 Amitriptyline Hydrochloride 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 1
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 [AIDAREX PHARMACEUTICALS LLC] 1 AMITRIPTYLINE ACTIVE MOIETY 1806D8D52K AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 D&C RED NO. 33 INACTIVE INGREDIENT 9DBA0SBB0L AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33261-626 AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC] 1 Legacy NDC, 3 package rows 20131204_348f7c87-ec55-4917-8cf6-4a3b749a72c1.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 33261-626-30 33261062630 30 in 1 BOTTLE, PLASTIC Historical 33261-626-60 33261062660 60 in 1 BOTTLE, PLASTIC Historical 33261-626-90 33261062690 90 in 1 BOTTLE, PLASTIC Historical