NDC 16729-397 - isosorbide mononitrate

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: 16729-397
Package NDCs from labels: 16729-397-15, 16729-397-01, 16729-397-16, 16729-397-17
Manufacturer: Accord Healthcare Inc. | Intas Pharmaceuticals Limited
Effective date: 2023-02-01
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
isosorbide mononitrate - Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2023-02-01	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
16729-397-01	2023-02-01	Isosorbide Mononitrate Extended-Release Tablets Rx only
16729-397-15	2023-02-01	Isosorbide Mononitrate Extended-Release Tablets Rx only
16729-397-16	2023-02-01	Isosorbide Mononitrate Extended-Release Tablets Rx only
16729-397-17	2023-02-01	Isosorbide Mononitrate Extended-Release Tablets Rx only
16729-397-01	2023-01-30	Isosorbide Mononitrate Extended-Release Tablets Rx only
16729-397-15	2023-01-30	Isosorbide Mononitrate Extended-Release Tablets Rx only
16729-397-16	2023-01-30	Isosorbide Mononitrate Extended-Release Tablets Rx only
16729-397-17	2023-01-30	Isosorbide Mononitrate Extended-Release Tablets Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16729-397-01	isosorbide mononitrate	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	4
16729-397-15	isosorbide mononitrate	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	4
16729-397-16	isosorbide mononitrate	500 in 1 BOTTLE	TABLET, EXTENDED RELEASE	500	4
16729-397-17	isosorbide mononitrate	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-397	ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE [ACCORD HEALTHCARE INC.]	4	4 package rows	20250101_cd439861-2e23-4e0e-bcdc-48e2ebdc4943.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 20 of 33 · 643 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
N-16	MGO ENERGIZER	DNA Labs, Inc.	8292b900-86c1-47ea-81da-b587439c7664	2025-01-09	Warnings	Exact identifier unii: ETJ7Z6XBU4
N-21	CALCIUM FLUORIDE, SILICON DIOXIDE, EUPHRASIA STRICTA, RUTA GRAVEOLENS WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, PHYSOSTIGMA VENENOSUM WHOLE, ANEMONE PULSATILLA, SODIUM CHLORIDE, AND SUS SCROFA EYE	DNA Labs, Inc.	89967941-c4ee-4598-a66d-8a93d69a4d65	2025-01-09	Warnings	Exact identifier unii: ETJ7Z6XBU4
N-18	OYSTER SHELL CALCIUM CARBONATE, CRUDE, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, NITRIC ACID, AND SUS SCROFA PINEAL GLAND	DNA Labs, Inc.	3565c5d5-dc68-4f3f-99ec-30f8952393e0	2025-01-09	Warnings	Exact identifier unii: ETJ7Z6XBU4
N-24	METABOLIN	DNA Labs, Inc.	559fca2b-1093-4bdf-be70-c453f87002c3	2025-01-09	Warnings	Exact identifier unii: ETJ7Z6XBU4
NO-WEAK-NAILS	GRAPHITE, THUJA OCCIDENTALIS LEAFY TWIG, AND SILICON DIOXIDE	Miers Laboratories	9158cd3f-4c27-40e9-bc07-fd560375c3a1	2025-01-09	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ferrum Silicicum Urtica	FERRUM SILICICUM URTICA	Uriel Pharmacy Inc.	09829ac4-c074-7315-e063-6394a90adf59	2025-01-07	Warnings	Exact identifier unii: ETJ7Z6XBU4
MIMIBO PREMIUM TOOTH	SILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATE	CONE MEDICAL Co., Ltd.	c0ff5df4-0b37-0b1b-e053-2a95a90a862c	2025-01-02	Warnings	Exact identifier unii: ETJ7Z6XBU4
MIMIBO PREMIUM TOOTH	SILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATE	CONE MEDICAL Co., Ltd.	c101881a-5a12-2e04-e053-2a95a90a3f57	2025-01-02	Warnings	Exact identifier unii: ETJ7Z6XBU4
NativeRemedies Acid Free-Flux	CALC PHOS 9X, CARBO VEG 6C, MAG CARB 6C, NAT PHOS 9X, SILICEA 9X	Silver Star Brands	d5012b1f-861e-40b8-e053-2a95a90a4fe2	2025-01-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
Mucus Clear Allergy Relief	ALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICA	Silver Star Brands	f49bdcc1-1939-6dc2-e053-2995a90a0a3b	2025-01-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
NativeRemedies Gout-Gone	ANTIMON CRUD, BENZOICUM AC, LEDUM, NUX VOM, QUERCUS, RHODODENDRON, SILICEA	Silver Star Brands	f66b42f0-8f5f-1aca-e053-2a95a90ae396	2025-01-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
NeuropathEase	AGARICUS MUSC, ARSENICUM ALB, HYPERICUM, PHOS, SILICEA	Silver Star Brands	7809e54a-018d-9cf6-e053-2a91aa0aedfe	2025-01-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
AllergiClear-M	ADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEA	Silver Star Brands	9d36096b-022f-5cfa-e053-2995a90a381f	2025-01-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
Trace Mineral Cord	ARGENTUM METALLICUM, AURUM METALLICUM, BORON CITRATE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CHROMIUM SULPHURICUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERRUM PHOSPHORICUM, GERMANIUM SESQUIOXIDE, IODIUM, KALI BROMATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, MANGANUM MURIATICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SELENIUM METALLICUM, SILICEA, SODIUM MOLYBDATE, STRONTIUM CARBONICUM, VANADIUM METALLICUM,	Energique, Inc.	902dd68d-5ce1-481e-8938-6487dcc68dfc	2024-12-19	Warnings	Exact identifier unii: ETJ7Z6XBU4
Geovita	CEREBRUM, CUPRUM MET, FERRUM MET, FORMICUM ACIDUM, SILICEA	RUBIMED AG	0fcb5c06-d414-456c-a0ef-28e14018a781	2024-11-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
Para-Si	JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER	Newton Laboratories, Inc.	27d41602-9dcb-eaa8-e063-6394a90a7cfa	2024-11-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Para-Si	JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER	Newton Laboratories, Inc.	27d4ddaf-9c07-a7fc-e063-6394a90adc0b	2024-11-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Para-Si	JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER	Newton Laboratories, Inc.	27d5997b-1cae-41c2-e063-6394a90ac74a	2024-11-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Hempvana Ultra Pain Relief Homeopathic Cream Platinum - Nerve Relief	ARNICA MONTANA, ACONITUM NAPELLUS, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, SECALE CORNUTUM, SILICEA	TELEBRANDS CORP	2787f88c-752e-cbaa-e063-6394a90a732c	2024-11-21	Warnings	Exact identifier unii: ETJ7Z6XBU4
Hempvana Ultra Pain Relief - Nerve Relief	ARNICA MONTANA, ACONITUM NAPELLUS, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, SECALE CORNUTUM, SILICEA	TELEBRANDS CORP	f93a1ed0-5046-0355-e053-6294a90a6a90	2024-11-20	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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