NDC 16729-394 - amlodipine besylate and olmesartan medoxomil

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: 16729-394
Package NDCs from labels: 16729-394-10, 16729-394-15, 16729-394-16, 16729-394-17
Manufacturer: Accord Healthcare Inc. | Intas Pharmaceuticals Limited
Effective date: 2019-08-14
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
POVIDONE K30 - Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2019-08-14	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16729-394-10	amlodipine besylate and olmesartan medoxomil	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
16729-394-15	amlodipine besylate and olmesartan medoxomil	90 in 1 BOTTLE	TABLET, FILM COATED	90	2
16729-394-16	amlodipine besylate and olmesartan medoxomil	500 in 1 BOTTLE	TABLET, FILM COATED	500	2
16729-394-17	amlodipine besylate and olmesartan medoxomil	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-394	AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL TABLET, FILM COATED [ACCORD HEALTHCARE INC.]	2	4 package rows	20220901_a855ce60-6918-490a-9158-3be5a0ef76b5.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 119 of 121 · 2,412 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Latte	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	e66734e4-34e7-4674-bb98-bdca931a176d	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Sand	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	bf78f7a7-93ca-425e-8571-175da6798e8e	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Sepia	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	418cdd4a-23f7-4181-b734-5ab7456494a2	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Toffee	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	50138c51-f424-4b07-b3eb-c0d31d8ecf16	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Cameo	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	01a861b9-0ab6-4c4c-a407-428a64509a1c	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Birch	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	d5431d62-fded-4cdc-81a1-5b5e3eb92873	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Protect and Perfect Intense Advanced All in One Foundation SPF 50 Tawny	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	52c3378f-6b99-42fa-900e-8a693864c615	2021-06-29	Warnings	Exact identifier unii: 15FIX9V2JP
Amlodipine Besylate	AMLODIPINE BESYLATE	Aphena Pharma Solutions - Tennessee, LLC	afcffa7b-03b7-499a-b50c-37b0e28c7737	2021-05-11	Warnings, Adverse reactions	Exact identifier unii: 864V2Q084H
Amlodipine besylate and Atorvastatin calcium	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	Dr. Reddy's Laboratories Inc	abee4a34-89cc-d886-192c-32582ab8f024	2021-02-16	Warnings, Adverse reactions	Exact identifier unii: 864V2Q084H
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	ScieGen Pharmaceuticals, Inc.	f15664a4-6b5f-4e88-ad56-c827ed90a40c	2021-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 6M97XTV3HD
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE	Teva Pharmaceuticals USA, Inc.	5c128ef2-60a6-40f3-b37f-ee139fe27987	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 864V2Q084H unii: 6M97XTV3HD
Amlodipine Besylate	AMLODIPINE BESYLATE	Proficient Rx LP	9f327d08-7661-4088-b554-2f9a99a113e7	2020-10-01	Warnings, Adverse reactions	Exact identifier unii: 864V2Q084H
Amlodipine Besylate	AMLODIPINE BESYLATE	Cipla USA Inc.	0c8d6b2f-3e4a-47a2-80e2-a34dcb337555	2020-09-09	Warnings, Adverse reactions	Exact identifier unii: 864V2Q084H
AMLODIPINE BESYLATE	AMLODIPINE BESYLATE	Proficient Rx LP	410aa0a5-43cf-455c-b51d-7dfbc24eee32	2020-02-01	Warnings, Adverse reactions	Exact identifier unii: 864V2Q084H
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Cool Vanilla	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	d701c221-9f68-47ff-b766-2f4f1998649f	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Amber	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	7f5e6872-4d26-410e-8afe-16a016f9a399	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Warm Ivory	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	1124ba7d-a328-409b-8c88-e74bb3e501f5	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Advanced All in One Foundation SPF 50 Honey	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	9c407dc7-fcde-4660-9a06-57bd8a6b867d	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Perfect and Perfect Intense Advanced All in One Foundation SPF 50 Chestnut	OCTINOXATE, TITANIUM DIOIXIDE, OCTISALATE	BCM Cosmetique SAS	f07e8bb2-30ae-4337-ad60-84f55f2ff354	2019-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Proficient Rx LP	e210f962-9b91-46c6-af8f-9f9a9ae84245	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 6M97XTV3HD

Reported adverse events (FAERS/openFDA)#

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