NDC 16729-176-17 - 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: 16729-176
Requested NDC: 16729-176-17
Package NDCs from labels: 16729-176-10, 16729-176-01, 16729-176-17
Manufacturer: Bryant Ranch Prepack
Effective date: 2024-08-19
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 - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-08-19	HUMAN PRESCRIPTION DRUG LABEL
Amitriptyline Hydrochloride Tablets, USP	REMEDYREPACK INC.	2024-01-26	HUMAN PRESCRIPTION DRUG LABEL
Amitriptyline Hydrochloride Tablets, USP	Accord Healthcare Inc. \| Intas Pharmaceuticals Limited. \| Intas Pharmaceuticals Limited	2022-11-05	HUMAN PRESCRIPTION DRUG LABEL
AMITRIPTYLINE HYDROCHLORIDE - Direct_Rx	Direct_Rx	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL
AMITRIPTYLINE HYDROCHLORIDE - Direct Rx	Direct Rx	2019-03-27	HUMAN PRESCRIPTION DRUG LABEL

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 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

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

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 2 of 142 · 2,828 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
S12 AIRBORNE	ALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEAT	Apex Energetics Inc.	bb0036c3-1e4d-5750-e053-2995a90ae895	2026-08-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Q Skin Science	SUNSCREEN	International Cosmeceuticals, Inc	59e4c3d0-ee4c-2350-e063-6394a90ac9d2	2026-08-25	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO zinc stick(GREEN)	TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE	Guangzhou Haishi Biological Technology Co., Ltd.	59c70c82-f7ff-9a04-e063-6294a90a7b3d	2026-08-24	Warnings	Exact identifier unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01	ZINC OXIDE, TITANIUM DIOXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	59d74e3f-e3fa-a7a9-e063-6294a90a76e5	2026-08-24	Warnings	Exact identifier unii: 15FIX9V2JP
Aging Eye Formula	CINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUM	Nutritional Specialties, Inc.	d5b44f79-5299-4b31-ba45-0e511cdbe17c	2026-08-24	Warnings	Exact identifier unii: ETJ7Z6XBU4
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Coupler LLC	598f6ffb-45c3-3cfc-e063-6294a90a56d1	2026-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 856834 unii: 26LUD4JO9K
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Coupler LLC	598f900c-552b-5653-e063-6294a90aff53	2026-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 856762 unii: 26LUD4JO9K
Bio Combination 28	SCHUESSLER SALTS	LDD Bioscience Private Limited	597caf33-5107-9dec-e063-6294a90a5fcd	2026-08-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body Original	TITANIUM DIOXIDE, ZINC OXIDE	Clutch, Inc.	4bbde755-e312-123e-e063-6294a90a467f	2026-08-20	Warnings	Exact identifier unii: 15FIX9V2JP
Psorinum Complex	PHOSPHORUS, SILICEA, SULPHUR, ALOE	BioActive Nutritional, Inc.	d4746927-e6d4-463d-a084-56ffc48d1e67	2026-08-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
Boneforce HP	CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALE	BioActive Nutritional, Inc.	d96ca52b-781d-431c-ad2a-a54fd57eb106	2026-08-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	e0d5b1f6-c1f2-4d5b-a1c3-aebe77843df2	2026-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 856834 unii: 26LUD4JO9K
HEADHUNTER SURF SCREEN SPF 50 SUNSCREEN	ZINC OXIDE,TITANIUM DIOXIDE	Guangzhou Tata Biotechnology Co., Ltd.	4339df13-77d3-31a1-e063-6394a90a5208	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
Cerebellum Thalamus A Aurm	CEREBELLUM THALAMUS A AURUM	Uriel Pharmacy Inc.	e1c395b8-9221-401f-8980-c91ff8843458	2026-08-17	Warnings	Exact identifier unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	HAMBLIN DERMATOLOGY	5942e64c-416e-7525-e063-6394a90a2839	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
Protect Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	Opal Day Spa	5943413a-48e1-0bdf-e063-6294a90a2fff	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	MedSpa By Beauty Bar LLC	5943ba3d-688e-9e9c-e063-6294a90afa9a	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	CORBY, JR., TERRY L.	594443fd-8e27-4ec6-e063-6294a90a3ff0	2026-08-17	Warnings	Exact identifier unii: 15FIX9V2JP
BM BM134 DROPS	ARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEA	BM Private Limited	59023500-89be-cc76-e063-6294a90a6e02	2026-08-14	Warnings	Exact identifier unii: ETJ7Z6XBU4
BM BM173 DROPS	ECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA UREN	BM Private Limited	59036ca4-e7bb-bbe7-e063-6394a90a410a	2026-08-14	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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