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 8 of 10 · 187 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEVONORGESTREL AND ETHINYL ESTRADIOL	LEVONORGESTREL AND ETHINYL ESTRADIOL	Mylan Pharmaceuticals Inc.	c3c00dc0-8834-45fb-9f5b-810a98cef59d	2022-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Wixela Inhub	FLUTICASONE PROPIONATE AND SALMETEROL	Mylan Pharmaceuticals Inc.	3beef422-8a07-4a45-9ba6-414511e4b7e2	2022-08-29	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Teriflunomide	TERIFLUNOMIDE	Mylan Pharmaceuticals Inc.	1824aae5-58af-43da-8231-435c8f118bc0	2022-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Tretinoin	TRETINOIN	Mylan Pharmaceuticals Inc.	ce5f4f14-5e60-4cc1-bcb3-1fa9b8aa9cd5	2022-07-25	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Prasugrel	PRASUGREL	Mylan Pharmaceuticals Inc.	41a4e332-6725-4cb7-940a-8291cf56cfe4	2022-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Colchicine	COLCHICINE	Mylan Pharmaceuticals Inc.	85acf34c-06c6-40ea-95f4-060d5de99277	2022-04-01	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
XULANE	NORELGESTROMIN AND ETHINYL ESTRADIOL	Mylan Pharmaceuticals Inc.	f7848550-086a-43d8-8ae5-047f4b9e4382	2022-03-04	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Doxazosin	DOXAZOSIN	Mylan Pharmaceuticals Inc.	6b887aa5-5edf-48c5-a480-dea8c35afa9d	2022-01-20	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Cyclosporine	CYCLOSPORINE	Mylan Pharmaceuticals Inc.	da3fa070-b512-4568-871a-dc8d5a949d13	2022-01-20	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL	ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL	Mylan Pharmaceuticals Inc.	563297dc-f27b-46e3-83de-bade17473d62	2021-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL	ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL	Mylan Pharmaceuticals Inc.	47263647-a9ac-40e4-83c0-d6500fa458cd	2021-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	Mylan Pharmaceuticals Inc.	aabda044-9f17-4f1f-bb8d-2a78c9066fdc	2021-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	Mylan Pharmaceuticals Inc.	054917fa-573b-4b16-a719-ece6c0909656	2021-11-29	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Bromocriptine Mesylate	BROMOCRIPTINE MESYLATE	Mylan Pharmaceuticals Inc.	72d8eefe-c066-41b6-8922-9586f1cf47a1	2021-10-13	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
AMLODIPINE AND VALSARTAN	AMLODIPINE AND VALSARTAN	Mylan Pharmaceuticals Inc.	aa7e7d95-520a-461c-b1b3-e588aeb6a613	2021-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Cystagon	CYSTEAMINE BITARTRATE	Mylan Pharmaceuticals Inc.	f495b76d-96c6-48e5-8fa3-30a4336628eb	2021-08-16	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Tamoxifen Citrate	TAMOXIFEN CITRATE	Mylan Pharmaceuticals Inc.	7ee3d3d2-85d1-4018-8e70-5ed8a64ae1f0	2021-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Fluorouracil	FLUOROURACIL	Mylan Pharmaceuticals Inc.	744737c5-0d96-4214-82ab-6cff016b1ea0	2021-06-30	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	c86084bc-33aa-eece-5a96-6c0dad2d1a32	2021-06-21	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
candesartan cilexetil	CANDESARTAN CILEXETIL	Mylan Pharmaceuticals Inc.	904b357e-97bf-475e-90a5-f0449f2a428e	2021-05-12	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.