NDC 0378-0197-05

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: 0378-0197
Requested NDC: 0378-0197-05
Package NDCs from labels: 0378-0197-05
Manufacturer: National Council for Prescription Drug Programs
Effective date: 2013-02-13
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2013-02-13	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
0378-0197-01	EA - Each	0378-0197	705c1658-2999-4e88-b00b-270645844035	1	2012-07-24
0378-0197-05	EA - Each	0378-0197	4ae28794-a74e-4ae7-bbf0-2fa45be72791	1	2013-02-13

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 10 · 193 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	Mylan Pharmaceuticals Inc.	3108a9bc-3378-459d-8f6b-bd5eff2ad657	2024-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	Mylan Pharmaceuticals Inc.	89948751-bd6e-4e9c-b87c-8782706c1097	2024-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Acitretin	ACITRETIN	Mylan Pharmaceuticals Inc.	2150bb0f-551b-4059-a97b-187d3ab22519	2023-12-20	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Mesalamine	MESALAMINE	Mylan Pharmaceuticals Inc.	c8b93ea3-0367-4605-b87f-06c3812ff3b7	2023-11-30	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Mylan Pharmaceuticals Inc.	e04e7c84-59c8-4a1d-8dfc-d72588b97b59	2023-11-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL	Mylan Pharmaceuticals Inc.	4423eebd-6397-4330-85a8-baa2e736767a	2023-11-09	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Lenalidomide	LENALIDOMIDE	Mylan Pharmaceuticals Inc.	76f6c1e7-985b-43d9-892c-849df50ae80e	2023-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
DROSPIRENONE AND ETHINYL ESTRADIOL	DROSPIRENONE AND ETHINYL ESTRADIOL	Mylan Pharmaceuticals Inc.	25f9b952-cc1d-454e-a3ec-834ba1774b6b	2023-09-22	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Fosamprenavir Calcium	FOSAMPRENAVIR CALCIUM	Mylan Pharmaceuticals Inc.	3a1424d8-844c-4e24-9ebd-b2c2b61b61a3	2023-09-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Mylan Pharmaceuticals Inc.	56ad5b97-8e5f-48a5-b2ba-a5484b43d018	2023-08-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Sunitinib Malate	SUNITINIB MALATE	Mylan Pharmaceuticals Inc.	4dbfcc02-dacc-4f0c-9f41-095783b68e27	2023-08-15	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	Mylan Pharmaceuticals Inc.	142c4b90-c9ab-45ce-9172-f1ea7d366686	2023-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Hyoscyamine ER	HYOSCYAMINE SULFATE	Mylan Pharmaceuticals Inc.	5bbce8c0-a9c9-45b9-8457-1542bd3d9449	2023-07-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Dexlansoprazole	DEXLANSOPRAZOLE	Mylan Pharmaceuticals Inc.	3f9699b5-7614-41cb-bd1d-ff02930e98f3	2023-07-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	Mylan Pharmaceuticals Inc.	5c1d0a3a-1b24-44a0-9c53-224365b65945	2023-05-31	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Valsartan and Hydrochlorothiazide	VALSARTAN AND HYDROCHLOROTHIAZIDE	Mylan Pharmaceuticals Inc.	3ba1f9f9-0037-4522-8605-e27dc8552b5b	2023-04-27	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	Mylan Pharmaceuticals Inc.	ada28708-ab65-4c07-a695-9141c5ce26bc	2023-04-20	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Telmisartan	TELMISARTAN	Mylan Pharmaceuticals Inc.	c3658bc8-1524-43db-930e-66f9ac01b808	2023-03-15	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Acamprosate Calcium	ACAMPROSATE CALCIUM ENTERIC-COATED	Mylan Pharmaceuticals Inc.	75ddfd10-55b2-426e-bc74-3413cd0d7c94	2022-11-17	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Eszopiclone	ESZOPICLONE	Mylan Pharmaceuticals Inc.	5469cc59-78f9-447a-9c33-12553bb4073d	2022-10-24	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.

Reported adverse events (FAERS/openFDA)#

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