Amitriptyline Hydrochloride

Product NDC: 0781-1486
11-digit product format: 007811486
Labeler code: 0781
Product ID: 0781-1486_9df45420-7268-454e-9624-8da48c97b7db
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amitriptyline Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA085968
Marketing category: ANDA
Marketing start: 1977-11-21
Substance: AMITRIPTYLINE HYDROCHLORIDE
Active strength: 10 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
Ingredient	Strength
AMITRIPTYLINE HYDROCHLORIDE	10 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	26LUD4JO9K
Rxcui	856762, 856773, 856783, 856834, 856845, 856853

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0781-1486-01	2020-08-18	C162847	48780-1	ab0e2407-2711-f274-e053-dbdaa90a6471	Amitriptyline Hydrochloride Tablets, USP
0781-1486-10	2020-08-18	C162847	48780-1	ab0e2407-2711-f274-e053-dbdaa90a6471	Amitriptyline Hydrochloride Tablets, USP
0781-1486-31	2020-08-18	C162847	48780-1	ab0e2407-2711-f274-e053-dbdaa90a6471	Amitriptyline Hydrochloride Tablets, USP
0781-1486-01	2020-07-22	C162847	48780-1	ab0e2407-2711-f274-e053-dbdaa90a6471	Amitriptyline Hydrochloride Tablets, USP
0781-1486-10	2020-07-22	C162847	48780-1	ab0e2407-2711-f274-e053-dbdaa90a6471	Amitriptyline Hydrochloride Tablets, USP
0781-1486-31	2020-07-22	C162847	48780-1	ab0e2407-2711-f274-e053-dbdaa90a6471	Amitriptyline Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0781-1486-01	Amitriptyline Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	27
0781-1486-10	Amitriptyline Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	27
0781-1486-31	Amitriptyline Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-1486-01	EA - Each	0781-1486	1ad2ad44-c5f2-4344-9e07-1527e6b3576f	1	2012-07-24
0781-1486-10	EA - Each	0781-1486	8bd14c90-b325-4126-9fc7-e694cb380fee	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMITRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]	16
AMITRIPTYLINE	ACTIVE MOIETY	1806D8D52K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]	16
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]	16
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]	16
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]	16
D&C RED NO. 7	INACTIVE INGREDIENT	ECW0LZ41X8	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]	16
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]	16
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]	16
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]	16
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]	16
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]	16
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]	16
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]	16
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]	16
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]	16
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]	16
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]	16
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]	16
AMITRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
AMITRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	4
AMITRIPTYLINE	ACTIVE MOIETY	1806D8D52K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	4
AMITRIPTYLINE	ACTIVE MOIETY	1806D8D52K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	4
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	4
D&C RED NO. 7	INACTIVE INGREDIENT	ECW0LZ41X8	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	4
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	4
AMITRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
AMITRIPTYLINE	ACTIVE MOIETY	1806D8D52K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
D&C RED NO. 7	INACTIVE INGREDIENT	ECW0LZ41X8	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
AMITRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
AMITRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
AMITRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
AMITRIPTYLINE	ACTIVE MOIETY	1806D8D52K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
AMITRIPTYLINE	ACTIVE MOIETY	1806D8D52K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
AMITRIPTYLINE	ACTIVE MOIETY	1806D8D52K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-1486	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SANDOZ INC]	26	Current NDC, Legacy NDC, 3 package rows	20240322_705a2bae-031d-4218-82fe-4346542c0baa.zip

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	705a2bae-031d-4218-82fe-4346542c0baa	27
856762	amitriptyline HCl 100 MG Oral Tablet	PSN	705a2bae-031d-4218-82fe-4346542c0baa	27
856773	amitriptyline HCl 150 MG Oral Tablet	PSN	705a2bae-031d-4218-82fe-4346542c0baa	27
856834	amitriptyline HCl 25 MG Oral Tablet	PSN	705a2bae-031d-4218-82fe-4346542c0baa	27
856845	amitriptyline HCl 50 MG Oral Tablet	PSN	705a2bae-031d-4218-82fe-4346542c0baa	27
856853	amitriptyline HCl 75 MG Oral Tablet	PSN	705a2bae-031d-4218-82fe-4346542c0baa	27
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	705a2bae-031d-4218-82fe-4346542c0baa	27
856762	amitriptyline hydrochloride 100 MG Oral Tablet	SCD	705a2bae-031d-4218-82fe-4346542c0baa	27
856773	amitriptyline hydrochloride 150 MG Oral Tablet	SCD	705a2bae-031d-4218-82fe-4346542c0baa	27
856834	amitriptyline hydrochloride 25 MG Oral Tablet	SCD	705a2bae-031d-4218-82fe-4346542c0baa	27
856845	amitriptyline hydrochloride 50 MG Oral Tablet	SCD	705a2bae-031d-4218-82fe-4346542c0baa	27
856853	amitriptyline hydrochloride 75 MG Oral Tablet	SCD	705a2bae-031d-4218-82fe-4346542c0baa	27
856783	amitriptyline HCl 10 MG Oral Tablet	PSN	eab6fbd5-50ca-4c52-bbe7-29d72d647daa	4
856783	amitriptyline HCl 10 MG Oral Tablet	PSN	94e984da-3b08-406f-8c10-e78844fca1ff	4
856783	amitriptyline HCl 10 MG Oral Tablet	PSN	4db1ade6-b7b0-0024-e054-00144ff8d46c	4
856834	amitriptyline HCl 25 MG Oral Tablet	PSN	eab6fbd5-50ca-4c52-bbe7-29d72d647daa	4
856834	amitriptyline HCl 25 MG Oral Tablet	PSN	94e984da-3b08-406f-8c10-e78844fca1ff	4
856845	amitriptyline HCl 50 MG Oral Tablet	PSN	94e984da-3b08-406f-8c10-e78844fca1ff	4
856853	amitriptyline HCl 75 MG Oral Tablet	PSN	eab6fbd5-50ca-4c52-bbe7-29d72d647daa	4
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	94e984da-3b08-406f-8c10-e78844fca1ff	4
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	eab6fbd5-50ca-4c52-bbe7-29d72d647daa	4
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	4db1ade6-b7b0-0024-e054-00144ff8d46c	4
856834	amitriptyline hydrochloride 25 MG Oral Tablet	SCD	eab6fbd5-50ca-4c52-bbe7-29d72d647daa	4
856834	amitriptyline hydrochloride 25 MG Oral Tablet	SCD	94e984da-3b08-406f-8c10-e78844fca1ff	4
856845	amitriptyline hydrochloride 50 MG Oral Tablet	SCD	94e984da-3b08-406f-8c10-e78844fca1ff	4
856853	amitriptyline hydrochloride 75 MG Oral Tablet	SCD	eab6fbd5-50ca-4c52-bbe7-29d72d647daa	4
856783	amitriptyline HCl 10 MG Oral Tablet	PSN	a159cfb6-b9a5-4d46-8320-7080daff33b9	2
856783	amitriptyline HCl 10 MG Oral Tablet	PSN	8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c	2
856783	amitriptyline HCl 10 MG Oral Tablet	PSN	8bb09e20-ba9b-3d53-e053-2a95a90a0c55	2
856783	amitriptyline HCl 10 MG Oral Tablet	PSN	7205c0e2-d7f9-3451-e053-2a95a90a69b0	2
856762	amitriptyline HCl 100 MG Oral Tablet	PSN	8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c	2
856773	amitriptyline HCl 150 MG Oral Tablet	PSN	8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c	2
856834	amitriptyline HCl 25 MG Oral Tablet	PSN	8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c	2
856845	amitriptyline HCl 50 MG Oral Tablet	PSN	8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c	2
856853	amitriptyline HCl 75 MG Oral Tablet	PSN	8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c	2
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	8bb09e20-ba9b-3d53-e053-2a95a90a0c55	2
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c	2
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	a159cfb6-b9a5-4d46-8320-7080daff33b9	2
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	7205c0e2-d7f9-3451-e053-2a95a90a69b0	2
856762	amitriptyline hydrochloride 100 MG Oral Tablet	SCD	8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c	2
856773	amitriptyline hydrochloride 150 MG Oral Tablet	SCD	8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c	2
856834	amitriptyline hydrochloride 25 MG Oral Tablet	SCD	8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c	2
856845	amitriptyline hydrochloride 50 MG Oral Tablet	SCD	8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c	2
856853	amitriptyline hydrochloride 75 MG Oral Tablet	SCD	8bf65c7f-4c8d-4df5-85e0-3ea1cc79a75c	2
856783	amitriptyline HCl 10 MG Oral Tablet	PSN	11f47c1a-992d-28eb-e054-00144ff88e88	1
856783	amitriptyline HCl 10 MG Oral Tablet	PSN	d441d278-2c54-4a22-83a3-4627d49aaae4	1
856762	amitriptyline HCl 100 MG Oral Tablet	PSN	d441d278-2c54-4a22-83a3-4627d49aaae4	1
856834	amitriptyline HCl 25 MG Oral Tablet	PSN	d441d278-2c54-4a22-83a3-4627d49aaae4	1
856845	amitriptyline HCl 50 MG Oral Tablet	PSN	d441d278-2c54-4a22-83a3-4627d49aaae4	1
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	d441d278-2c54-4a22-83a3-4627d49aaae4	1
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	11f47c1a-992d-28eb-e054-00144ff88e88	1
856762	amitriptyline hydrochloride 100 MG Oral Tablet	SCD	d441d278-2c54-4a22-83a3-4627d49aaae4	1
856834	amitriptyline hydrochloride 25 MG Oral Tablet	SCD	d441d278-2c54-4a22-83a3-4627d49aaae4	1
856845	amitriptyline hydrochloride 50 MG Oral Tablet	SCD	d441d278-2c54-4a22-83a3-4627d49aaae4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-1486-01	00781148601	100 TABLET, FILM COATED in 1 BOTTLE (0781-1486-01)	1977-11-21	0000-00-00	No	No	Current
0781-1486-10	00781148610	1000 TABLET, FILM COATED in 1 BOTTLE (0781-1486-10)	1977-11-21	0000-00-00	No	No	Current
0781-1486-31	00781148631	30 in 1 BOTTLE					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amitriptyline Hydrochloride Tablets, USP	Sandoz Inc	2025-05-30	HUMAN PRESCRIPTION DRUG LABEL	27
Amitriptyline Hydrochloride - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	4
Amitriptyline Hydrochloride Tablets, USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-12-30	HUMAN PRESCRIPTION DRUG LABEL	2
Amitriptyline Hydrochloride Tablets, USP	Medsource Pharmaceuticals	2019-12-27	HUMAN PRESCRIPTION DRUG LABEL	2
Amitriptyline Hydrochloride Tablets, USP	Carilion Materials Management	2016-03-08	HUMAN PRESCRIPTION DRUG LABEL	2
Amitriptyline Hydrochloride Tablets, USP	Blenheim Pharmacal, Inc.	2015-03-23	HUMAN PRESCRIPTION DRUG LABEL	1
AMITRIPTYLINE HYDROCHLORIDE TABLETS, USP	GLENVIEW PHARMA INC.	2014-09-03	HUMAN PRESCRIPTION DRUG LABEL	4
Amitriptyline Hydrochloride Tablets, USP	STAT Rx USA LLC	2012-01-04	HUMAN PRESCRIPTION DRUG LABEL	4
Amitriptyline Hydrochloride Tablets, USP	H.J. Harkins Company, Inc. \| Sandoz Inc	2011-10-11	HUMAN PRESCRIPTION DRUG LABEL	1
Amitriptyline Hydrochloride Tablets, USP	Physicians Total Care, Inc.	2010-12-07	HUMAN PRESCRIPTION DRUG LABEL	2
Amitriptyline Hydrochloride Tablets, USP	Rebel Distributors Corp.	2010-02-01	HUMAN PRESCRIPTION DRUG LABEL	1

Amitriptyline Hydrochloride

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

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