NDC 85534-0064-01 - Omeprazole

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: 85534-0064
Requested NDC: 85534-0064-01
Package NDCs from labels: 85534-0064-0, 85534-0064-1, 85534-0064-2, 85534-0064-3, 85534-0064-01
Manufacturer: HAWAII REPACK, INC.
Effective date: 2026-07-13
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Omeprazole - HAWAII REPACK, INC.	HAWAII REPACK, INC.	2026-07-13	HUMAN PRESCRIPTION DRUG LABEL

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 112 of 117 · 2,322 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Twin Med LLC	346141b5-b49d-489a-84eb-18df8b940460	2023-01-06	Warnings	Exact identifier unii: KG60484QX9
Omeprazole	OMEPRAZOLE	HARRIS TEETER	c618964f-4b16-448e-851b-e6b2a816c660	2022-12-27	Warnings	Exact identifier unii: KG60484QX9
Omeprazole	OMEPRAZOLE	Camber Consumer Care Inc	9c856d3a-e38f-4006-a43a-ec1a9fa0f057	2022-11-28	Warnings	Exact identifier unii: KG60484QX9
Omeprazole, Sodium bicarbonate	OMEPRAZOLE, SODIUM BICARBONATE	Guardian Drug Company	e5c6c2cf-fb3b-456a-a0a0-be396d6f8319	2022-11-08	Warnings, Adverse reactions	Exact identifier unii: KG60484QX9
Omeprazole	OMEPRAZOLE	Proficient Rx LP	9786b04f-f827-460b-91bc-c0ac967f95dd	2022-11-01	Warnings, Adverse reactions	Exact identifier rxcui: 200329 unii: KG60484QX9
Addiclenz	BETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM	Deseret Biologicals, Inc.	e39235ea-2a2f-44a7-92d6-fb1d428ebabd	2022-05-12	Warnings	Exact identifier unii: 15FIX9V2JP
Omeprazole	OMEPRAZOLE	Strategic Sourcing Services	dfa91081-3917-4dfc-9789-76800f57bb31	2022-05-11	Warnings	Exact identifier unii: KG60484QX9
Omeprazole	OMEPRAZOLE	Proficient Rx LP	2d99b4fd-49b3-403d-96a4-0cceda85a95c	2022-04-01	Warnings, Adverse reactions	Exact identifier application number: ANDA091672 rxcui: 198051 unii: KG60484QX9
Omeprazole	OMEPRAZOLE	Proficient Rx LP	2fc5065c-5850-469b-b357-fa4df30a8f78	2022-04-01	Warnings, Adverse reactions	Exact identifier rxcui: 198051 unii: KG60484QX9
omeprazole	OMEPRAZOLE	Rite Aid	b1ba65d1-8f68-4bae-bb9d-776bba348346	2022-03-03	Warnings	Exact identifier rxcui: 198051
Omeprazole	OMEPRAZOLE	Xiromed, LLC	38bd8e13-591e-f11b-7d8a-11717c56493c	2022-02-15	Warnings, Adverse reactions	Exact identifier rxcui: 198051 rxcui: 200329 rxcui: 199119 unii: KG60484QX9
Omeprazole	OMEPRAZOLE MAGNESIUM	Walgreen Company	537b9a46-ecc8-4537-9657-c9ff7821dd4b	2021-12-03	Warnings	Exact identifier rxcui: 198051
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm Ivory	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	97e7ece8-a705-4988-ba52-6d3f11573521	2021-12-01	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Chestnut	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	6a44f926-11b4-4bc4-8d5d-721a89c4f0cc	2021-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Hazelnut	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	b58af664-b0fd-4585-8417-7c20954d7aff	2021-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Umber	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	7bbd1334-fae8-4274-b927-a099af764345	2021-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cedar	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	970571f9-3d6b-46ae-a668-745de1911fa2	2021-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Wheat	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	542e1b2e-f63c-466b-b5ac-6c147a0e9dec	2021-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm Beige	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	21b65c12-6f67-4053-9508-6b2709cc1fb8	2021-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Beige	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	8ea4c470-ebd5-448e-b72a-ccd1113de0ab	2021-11-08	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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