AMITRIPTYLINE HYDROCHLORIDE

Product NDC: 16729-176
11-digit product format: 167290176
Labeler code: 16729
Product ID: 16729-176_387e8b29-cf4d-4859-e063-6294a90ad470
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMITRIPTYLINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Accord Healthcare Inc.
Application: ANDA202446
Marketing category: ANDA
Marketing start: 2014-12-26
Substance: AMITRIPTYLINE HYDROCHLORIDE
Active strength: 150 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 1.

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	Approval date
A202446-001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04
A202446-002	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04
A202446-003	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04
A202446-004	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04
A202446-005	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04
A202446-006	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A202446-001	AB
A202446-002	AB
A202446-003	AB
A202446-004	AB
A202446-005	AB
A202446-006	AB

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 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202446-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202446-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202446-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202446-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202446-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202446-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202446-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202446-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202446-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202446-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202446-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202446-004	AB	1	`2680178bc6a6…`

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	150 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e5006e90-7f2e-4341-bcdb-f83027a8fc39	Product name	6	20240611
6f1277d7-db3a-63fa-be84-d390d1482706	Product name	1	20140508
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16729-176-01	AMITRIPTYLINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100	8
16729-176-10	AMITRIPTYLINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
16729-176-17	AMITRIPTYLINE HYDROCHLORIDE	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-176-01	EA - Each	16729-176	72b3fdec-659f-4ca6-9228-283ce4dfba96	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMITRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	3
AMITRIPTYLINE	ACTIVE MOIETY	1806D8D52K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	3
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	3
Amitriptyline Hydrochloride	ACTIVE INGREDIENT	26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]	1
AMITRIPTYLINE	ACTIVE MOIETY	1806D8D52K	AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]	1
Calcium Sulfate	INACTIVE INGREDIENT	WAT0DDB505	AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]	1
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]	1
Hydroxypropyl Cellulose	INACTIVE INGREDIENT	RFW2ET671P	AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]	1
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]	1
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]	1
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	AMITRIPTYLINE HYDROCHLORIDE TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-176	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	8	Current NDC, Legacy NDC, 3 package rows	20221106_1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	Northwind Health Company, LLC	e3afe026-7072-0a7d-e053-2995a90a52d4	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446
Amitriptyline HCL	AMITRIPTYLINE HCL	Advanced Rx Pharmacy of Tennessee, LLC	ca66c2fc-6724-f4cd-e053-2995a90a42cf	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	2024-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	58ff9a82-5de6-a1b0-e053-2991aa0a84ba	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	5a5a4040-5395-54ac-e053-2991aa0aa4ab	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	9440dd10-2f0d-42a7-a037-3ab8729708f6	2023-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	df5aee40-ffa9-4cf3-ab5f-30253f43092b	2022-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE	549-18-8	AMITRIPTYLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
856783	amitriptyline HCl 10 MG Oral Tablet	PSN	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856762	amitriptyline HCl 100 MG Oral Tablet	PSN	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856773	amitriptyline HCl 150 MG Oral Tablet	PSN	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856834	amitriptyline HCl 25 MG Oral Tablet	PSN	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856845	amitriptyline HCl 50 MG Oral Tablet	PSN	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856853	amitriptyline HCl 75 MG Oral Tablet	PSN	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856762	amitriptyline hydrochloride 100 MG Oral Tablet	SCD	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856773	amitriptyline hydrochloride 150 MG Oral Tablet	SCD	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856834	amitriptyline hydrochloride 25 MG Oral Tablet	SCD	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856845	amitriptyline hydrochloride 50 MG Oral Tablet	SCD	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856853	amitriptyline hydrochloride 75 MG Oral Tablet	SCD	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856783	amitriptyline HCl 10 MG Oral Tablet	PSN	1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd	8
856762	amitriptyline HCl 100 MG Oral Tablet	PSN	1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd	8
856773	amitriptyline HCl 150 MG Oral Tablet	PSN	1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd	8
856834	amitriptyline HCl 25 MG Oral Tablet	PSN	1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd	8
856845	amitriptyline HCl 50 MG Oral Tablet	PSN	1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd	8
856853	amitriptyline HCl 75 MG Oral Tablet	PSN	1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd	8
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd	8
856762	amitriptyline hydrochloride 100 MG Oral Tablet	SCD	1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd	8
856773	amitriptyline hydrochloride 150 MG Oral Tablet	SCD	1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd	8
856834	amitriptyline hydrochloride 25 MG Oral Tablet	SCD	1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd	8
856845	amitriptyline hydrochloride 50 MG Oral Tablet	SCD	1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd	8
856853	amitriptyline hydrochloride 75 MG Oral Tablet	SCD	1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd	8
856773	amitriptyline HCl 150 MG Oral Tablet	PSN	6dc30652-39c8-49a9-b411-3d238bc0ef1a	4
856834	amitriptyline HCl 25 MG Oral Tablet	PSN	6dc30652-39c8-49a9-b411-3d238bc0ef1a	4
856773	amitriptyline hydrochloride 150 MG Oral Tablet	SCD	6dc30652-39c8-49a9-b411-3d238bc0ef1a	4
856834	amitriptyline hydrochloride 25 MG Oral Tablet	SCD	6dc30652-39c8-49a9-b411-3d238bc0ef1a	4
856773	amitriptyline HCl 150 MG Oral Tablet	PSN	9480586d-1e6b-2792-e053-2995a90adbb4	2
856773	amitriptyline hydrochloride 150 MG Oral Tablet	SCD	9480586d-1e6b-2792-e053-2995a90adbb4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-176-01	16729017601	100 TABLET, FILM COATED in 1 BOTTLE (16729-176-01)	2014-12-26	0000-00-00	No	No	Current
16729-176-10	16729017610	30 in 1 BOTTLE					Historical
16729-176-17	16729017617	1000 in 1 BOTTLE					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amitriptyline Hydrochloride Tablets, USP	Bryant Ranch Prepack	2024-08-19	HUMAN PRESCRIPTION DRUG LABEL	22
Amitriptyline Hydrochloride Tablets, USP	REMEDYREPACK INC.	2024-01-26	HUMAN PRESCRIPTION DRUG LABEL	6
Amitriptyline Hydrochloride Tablets, USP	Accord Healthcare Inc. \| Intas Pharmaceuticals Limited. \| Intas Pharmaceuticals Limited	2022-11-05	HUMAN PRESCRIPTION DRUG LABEL	8
AMITRIPTYLINE HYDROCHLORIDE	Direct_Rx	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	2
AMITRIPTYLINE HYDROCHLORIDE	Direct Rx	2019-03-27	HUMAN PRESCRIPTION DRUG LABEL	4