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 1 of 10 · 196 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac sodium and Misoprostol	DICLOFENAC SODIUM AND MISOPROSTOL	Mylan Pharmaceuticals Inc.	a7701e8c-4e16-4165-8b83-de2c08d5ded3	2026-08-31	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Sumatriptan Succinate	SUMATRIPTAN SUCCINATE	Mylan Pharmaceuticals Inc.	1d2cd01c-05e7-44cf-a71d-0f474e826b7e	2026-08-26	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Sulfasalazine	SULFASALAZINE	Mylan Pharmaceuticals Inc.	257cee60-b68f-4c2b-b57d-8e4d73d17e09	2026-08-25	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
misoprostol	MISOPROSTOL	Mylan Pharmaceuticals Inc.	c4fe14fb-0a43-4c31-9cd6-29eb0d156705	2026-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Sulfasalazine	SULFASALAZINE	Mylan Pharmaceuticals Inc.	48fbc535-a33a-45ee-85ff-9d1ec9b31d9c	2026-08-25	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Saxagliptin and Metformin	SAXAGLIPTIN AND METFORMIN	Mylan Pharmaceuticals Inc.	cbf8677c-cafe-48bc-8844-0cc6547886bd	2026-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Amnesteem	ISOTRETINOIN	Mylan Pharmaceuticals Inc.	b2cb63c9-f825-4991-9a2c-6260f1bbcc2c	2026-08-15	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Mylan Pharmaceuticals Inc.	b52bdaf7-3b54-4165-9ab0-9dfa08170e47	2026-08-06	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Ethosuximide	ETHOSUXIMIDE	Mylan Pharmaceuticals Inc.	19c924c2-f558-4c78-9277-2d7e0df2f505	2026-07-24	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Rifabutin	RIFABUTIN	Mylan Pharmaceuticals Inc.	c2026b67-4755-4236-96b6-a6b5e7399707	2026-07-20	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Nevirapine	NEVIRAPINE	Mylan Pharmaceuticals Inc.	c6e93829-7024-48f6-8023-da6ff27dfc0a	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Cimetidine	CIMETIDINE	Mylan Pharmaceuticals Inc.	06c0a509-026f-44e0-9975-a94a8de51d43	2026-07-15	Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Imatinib Mesylate	IMATINIB	Mylan Pharmaceuticals Inc.	a1787fad-3612-43e1-98fa-ce62361e0b3c	2026-07-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Triazolam	TRIAZOLAM	Mylan Pharmaceuticals Inc.	5add318e-11b9-42f8-b052-0d8cebb32fcf	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Linezolid	LINEZOLID	Mylan Pharmaceuticals Inc.	83a84897-ccca-42a1-ab1a-bbf1d43a982b	2026-07-09	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Cabergoline	CABERGOLINE	Mylan Pharmaceuticals Inc.	e497366b-a124-4d7f-bd45-a883c392d4bb	2026-06-30	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Clonidine	CLONIDINE	Mylan Pharmaceuticals Inc.	7adfc439-e6d0-4593-87dd-0eef36d33c6d	2026-06-23	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Methylprednisolone	METHYLPREDNISOLONE	Mylan Pharmaceuticals Inc.	22dd75d6-f89a-44f7-8ca6-b64c4e9806dd	2026-06-22	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Atorvastatin Calcium	ATORVASTATIN CALCIUM	Mylan Pharmaceuticals Inc.	d0a0feb6-84f0-4693-a11f-eb4f7ae0a87d	2026-06-15	Warnings, Adverse reactions	Name fallback manufacturer name: Mylan Pharmaceuticals Inc.
Metformin Hydrochloride	METFORMIN	Mylan Pharmaceuticals Inc.	7e41818c-60e9-4bcf-9586-7bb8d33d5e89	2026-06-15	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.