NDC 0378-2675-93 - Amitriptyline Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0378-2675
Requested NDC: 0378-2675-93
Package NDCs from labels: 0378-2675-01, 0378-2675-93
Manufacturer: Mylan Institutional Inc.
Effective date: 2020-11-24
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Amitriptyline Hydrochloride - Mylan Institutional Inc.	Mylan Institutional Inc.	2020-11-24	HUMAN PRESCRIPTION DRUG LABEL
Amitriptyline Hydrochloride - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2016-03-04	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-2675-01	EA - Each	0378-2675	6801c84e-05b8-49de-af89-1c0b96d4c606	1	2012-07-24
0378-2675-93	EA - Each	0378-2675	0db7da0e-457d-482e-b1f8-4429e73bb47f	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 [MYLAN PHARMACEUTICALS INC.]	9
Amitriptyline	ACTIVE MOIETY	1806D8D52K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	9
Calcium Sulfate	INACTIVE INGREDIENT	WAT0DDB505	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	9
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	9
D&C Red No. 30	INACTIVE INGREDIENT	2S42T2808B	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	9
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	9
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	9
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	9
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	9
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	9
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	9
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	9
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	9
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	9
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	9
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	9
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	9
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	9
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	9
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	9
Amitriptyline Hydrochloride	ACTIVE INGREDIENT	26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	8
Amitriptyline	ACTIVE MOIETY	1806D8D52K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	8
Calcium Sulfate	INACTIVE INGREDIENT	WAT0DDB505	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	8
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	8
D&C Red No. 30	INACTIVE INGREDIENT	2S42T2808B	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	8
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	8
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	8
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	8
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	8
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	8
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	8
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	8
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	8
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	8
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	8
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	8
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	8
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	8
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]	8

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 7 of 140 · 2,781 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nail Fungus Control Extra Strength	CALENDULA OFFICINALIS FLOWERING TOP, SILICON DIOXIDE, AND HYPERICUM PERFORATUM	Forces of Nature	d02b88a6-1999-4dcd-91b5-fad88a664fcb	2026-06-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
Nerve Pain	ARABICA COFFEE BEAN, SILICON DIOXIDE, AND HYPERICUM PERFORATUM	Forces of Nature	a9c3ba2e-9254-4ccd-9fe9-7a360fdf2bb7	2026-06-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
Scar Control	CALENDULA OFFICINALIS FLOWERING TOP, ALLYLTHIOUREA, AND SILICON DIOXIDE	Forces of Nature	595c3423-6b52-48fc-8a95-00b53c1ecc7b	2026-06-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
BM BM186 DROPS	ARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICA	Total Operations Management LLC DBA:Bestmade Natural Products Micro	54243745-bd67-19c1-e063-6394a90a4b72	2026-06-13	Warnings	Exact identifier unii: ETJ7Z6XBU4
BM BM186 DROPS	ARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICA	BM Private Limited	540d8fbe-3bdb-1b54-e063-6394a90a114d	2026-06-12	Warnings	Exact identifier unii: ETJ7Z6XBU4
BM BM5 DROPS	APIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCC	Total Operations Management LLC DBA:Bestmade Natural Products Micro	540e4ee3-596f-4cea-e063-6294a90a6a60	2026-06-12	Warnings	Exact identifier unii: ETJ7Z6XBU4
Sunbetter Daily Mineral Protection Broad Spectrum SPF 75 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	SKINBETTER SCIENCE LLC	54106748-9810-d3ff-e063-6394a90a5b7a	2026-06-12	Warnings	Exact identifier unii: 15FIX9V2JP
Sunbetter Daily Mineral Protection Broad Spectrum SPF 70 Sheer Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	SKINBETTER SCIENCE LLC	5410e0ed-aed5-3279-e063-6294a90a0c3e	2026-06-12	Warnings	Exact identifier unii: 15FIX9V2JP
it cosmetics Your Skin But Better CC Plus Natural Matte Color Correcting Pore Refining Full Coverage Skin Balancing Serum Broad Spectrum SPF 40 Sunscreen	ENSULIZOLE, OCTISALATE AND TITANIUM DIOXIDE	IT COSMETICS, LLC	f2990320-b61d-40b8-ba79-18d6b37e7f52	2026-06-11	Warnings	Exact identifier unii: 15FIX9V2JP
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	9ced0126-d597-48fb-96d3-577333760048	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 26LUD4JO9K
Jacksons Cell Salts SKIN BALANCE	CALC SULPH, KALI SULPH, SILICEA	Zettl Health Inc.	54012f03-4c34-42f5-e063-6394a90aacc5	2026-06-11	Warnings	Exact identifier unii: ETJ7Z6XBU4
BM BM5 DROPS	APIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCC	BM Private Limited	53e763ee-9a44-a914-e063-6394a90aeb3c	2026-06-10	Warnings	Exact identifier unii: ETJ7Z6XBU4
GUNA-AWARENESS	BETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE - SUS SCROFA FRONTAL LOBE - SUS SCROFA TEMPORAL LOBE - THYROTROPIN ALFA - UBIDECARENONE - VANADIUM - ZINC - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN -	Guna spa	10e46b39-7903-4390-b72d-865291245b4c	2026-06-10	Warnings	Exact identifier unii: ETJ7Z6XBU4
BM BIO28 ALCOHOL	CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA	BM Private Limited	53d1c51a-77eb-bb3c-e063-6394a90aab3f	2026-06-09	Warnings	Exact identifier unii: ETJ7Z6XBU4
BM BIO18	CALC FLUOR, CALC SULF, SILICEA.	Total Operations Management LLC DBA:Bestmade Natural Products Micro	53d3c1d6-d0ba-5ea7-e063-6394a90a0294	2026-06-09	Warnings	Exact identifier unii: ETJ7Z6XBU4
RE-NUTRIV AGE REVERSAL VITAL RADIANCE SERUM FOUNDATION SPF 20	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	53d76b02-442e-7a5d-e063-6394a90ae1b3	2026-06-09	Warnings	Exact identifier unii: 15FIX9V2JP
FUTURIST HYDRATING COLLAGEN-PEPTIDE MAKEUP BROAD SPECTRUM SPF 20	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	53d9d689-4a86-5b9c-e063-6394a90aef18	2026-06-09	Warnings	Exact identifier unii: 15FIX9V2JP
BM Silicea	SILICEA	Total Operations Management LLC DBA:Bestmade Natural Products Micro	53bb3927-6053-eb3d-e063-6394a90a5ddf	2026-06-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
Scrofularoforce	RUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANA	BioActive Nutritional, Inc.	737cd410-0405-41b0-b7f2-29bb20037849	2026-06-08	Warnings	Exact identifier unii: ETJ7Z6XBU4
Eryfotona Ageless Tinted Lightweight Emulsion Sunscreen	TITANIUM DIOXIDE	ISDIN Corp.	293a1116-e8a2-495f-83db-20dd82ed13c2	2026-06-08	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.