NDC 16729-176-10 - 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: 16729-176-10
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 1 of 142 · 2,828 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lymph Tonic II	ECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANA	BioActive Nutritional, Inc.	0e3265b0-b210-4a4c-80d2-8a9712981d4e	2026-09-17	Warnings	Exact identifier unii: ETJ7Z6XBU4
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	61b29703-cfc2-45c7-ae24-7bf3b77e8587	2026-09-09	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 856762 unii: 26LUD4JO9K
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	W Aesthetics	5b0f2c8f-d6fa-5e25-e063-6394a90a084d	2026-09-09	Warnings	Exact identifier unii: 15FIX9V2JP
Leader Artificial Tears 15 mL	POLYVINYL ALCOHOL, POVIDONE	Cardinal Health	8cccc589-3a8e-baad-e053-2a95a90ab8c7	2026-09-09	Warnings	Exact identifier unii: 532B59J990
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	e0aa02a9-3e2d-44c5-a6b9-843c80102249	2026-09-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 856853 unii: 26LUD4JO9K
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	4e520c63-1cf6-40f6-a51c-3f9b0e181342	2026-09-08	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 856834 rxcui: 856853 rxcui: 856783 rxcui: 856845 rxcui: 856773 rxcui: 856762 unii: 26LUD4JO9K
Calamine	CALAMINE, PRAMOXINE HCL	United Natural Foods, Inc. dba UNFI	0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea	2026-09-04	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	c072c1b3-ed8a-4f1e-ba6c-580a2b2c8f58	2026-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 856834 unii: 26LUD4JO9K
Psoriasis Control	CENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDE	Forces of Nature	2db33771-0bb9-49f8-84fa-dddc28e4ba26	2026-09-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS	POVIDONE, POLYVINYL ALCOHOL SOLUTION	Harrow Eye, LLC	049e9cc9-0663-53bc-e063-6294a90a2c4f	2026-09-04	Warnings	Exact identifier unii: 532B59J990
BMNP Silicea	SILICEA	Total Operations Management LLC DBA:Bestmade Natural Products Micro	5a58454f-aed6-24ba-e063-6294a90a47fb	2026-08-31	Warnings	Exact identifier unii: ETJ7Z6XBU4
Calamine	FERRIC OXIDE RED	Your Military Exchanges	af95a66c-f063-4019-80c6-6f7dc4fee4d8	2026-08-28	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	bb02d7b8-8f1a-4cc4-b763-223e6894f02c	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 856762 unii: 26LUD4JO9K
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	4132f91e-6f24-476a-9028-bab86ad0598e	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 856834 unii: 26LUD4JO9K
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50	SUNSCREEN SPF50	Guangzhou Meixi Biotechnology Co., Ltd.	5a0b4bd2-f6ad-35dc-e063-6294a90a8a66	2026-08-27	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO Hydrating Lightweight Sunscreen	AVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDE	Guangdong Aimu Biological Technology Co., Ltd	59eeaea1-d726-99f3-e063-6394a90aeea3	2026-08-26	Warnings	Exact identifier unii: 15FIX9V2JP
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	5dc3c2d7-60a2-4754-be33-1f9401c925a4	2026-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 856845 unii: 26LUD4JO9K
Argentum Quartz	ARGENTUM QUARTZ	Uriel Pharmacy Inc.	765c8c8f-0727-45da-a77e-c3907a3d0793	2026-08-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Calamine Plus	CALAMINE, PRAMOXINE HYDROCHLORIDE	Kroger Company	44fdd5a4-3cac-15e5-e063-6294a90adb52	2026-08-26	Warnings	Exact identifier unii: 1K09F3G675
Endometrium Argentum	ENDOMETRIUM ARGENTUM	Uriel Pharmacy Inc	d2d1428a-c8b5-9529-e053-2995a90a2343	2026-08-26	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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