NDC 68084-128-11 - 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: 68084-128
Requested NDC: 68084-128-11
Package NDCs from labels: 68084-128-11, 68084-128-01
Manufacturer: American Health Packaging
Effective date: 2025-02-17
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Omeprazole - American Health Packaging	American Health Packaging	2025-02-17	HUMAN PRESCRIPTION DRUG LABEL
Omeprazole - Cardinal Health 107, LLC	Cardinal Health 107, LLC	2024-09-25	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68084-128-01	Omeprazole	100 in 1 BOX, UNIT-DOSE	CAPSULE, DELAYED RELEASE	100		15
68084-128-11	Omeprazole	1 in 1 BLISTER PACK	CAPSULE, DELAYED RELEASE	1		15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-128	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	15	Legacy NDC, 2 package rows	20250223_a17e415e-a559-4a8d-a455-699184a01523.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-128-01	EA - Each	68084-128	3e70c7e3-2c38-433e-a053-c9126b1fa455	1	2012-07-24
68084-128-11	EA - Each	68084-128	fde13598-939c-40d9-ba98-d1bbf686baa3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Omeprazole	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
omeprazole	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
crospovidone	INACTIVE INGREDIENT	68401960MK	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
D&C Red No. 28	INACTIVE INGREDIENT	767IP0Y5NH	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
gelatin	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
mannitol	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
meglumine	INACTIVE INGREDIENT	6HG8UB2MUY	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
methacrylic acid - ethyl acrylate copolymer (1:1) type A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
poloxamer 407	INACTIVE INGREDIENT	TUF2IVW3M2	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
triethyl citrate	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]	7
Omeprazole	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
omeprazole	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
butyl alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
crospovidone	INACTIVE INGREDIENT	68401960MK	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
D&C Red No. 28	INACTIVE INGREDIENT	767IP0Y5NH	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
gelatin	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
mannitol	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
meglumine	INACTIVE INGREDIENT	6HG8UB2MUY	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
methacrylic acid - ethyl acrylate copolymer (1:1) type A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
poloxamer 407	INACTIVE INGREDIENT	TUF2IVW3M2	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
shellac	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3
triethyl citrate	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]	3

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 155 · 3,092 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lymph Tonic II	ECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANA	BioActive Nutritional, Inc.	0e3265b0-b210-4a4c-80d2-8a9712981d4e	2026-09-17	Warnings	Exact identifier unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	W Aesthetics	5b0f2c8f-d6fa-5e25-e063-6394a90a084d	2026-09-09	Warnings	Exact identifier unii: 15FIX9V2JP
Leader Artificial Tears 15 mL	POLYVINYL ALCOHOL, POVIDONE	Cardinal Health	8cccc589-3a8e-baad-e053-2a95a90ab8c7	2026-09-09	Warnings	Exact identifier unii: FZ989GH94E
Psoriasis Control	CENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDE	Forces of Nature	2db33771-0bb9-49f8-84fa-dddc28e4ba26	2026-09-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS	POVIDONE, POLYVINYL ALCOHOL SOLUTION	Harrow Eye, LLC	049e9cc9-0663-53bc-e063-6294a90a2c4f	2026-09-04	Warnings	Exact identifier unii: FZ989GH94E
BMNP Silicea	SILICEA	Total Operations Management LLC DBA:Bestmade Natural Products Micro	5a58454f-aed6-24ba-e063-6294a90a47fb	2026-08-31	Warnings	Exact identifier unii: ETJ7Z6XBU4
Omeprazole	OMEPRAZOLE	Amazon.com Services LLC	94faa721-e925-4033-8661-d1990dfa920d	2026-08-30	Warnings	Exact identifier unii: KG60484QX9
Omeprazole	OMEPRAZOLE	REMEDYREPACK INC.	63b3982a-b541-4b0d-99d4-93a673e57d46	2026-08-28	Warnings, Adverse reactions	Exact identifier rxcui: 198051 unii: KG60484QX9
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50	SUNSCREEN SPF50	Guangzhou Meixi Biotechnology Co., Ltd.	5a0b4bd2-f6ad-35dc-e063-6294a90a8a66	2026-08-27	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO Hydrating Lightweight Sunscreen	AVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDE	Guangdong Aimu Biological Technology Co., Ltd	59eeaea1-d726-99f3-e063-6394a90aeea3	2026-08-26	Warnings	Exact identifier unii: 15FIX9V2JP
Argentum Quartz	ARGENTUM QUARTZ	Uriel Pharmacy Inc.	765c8c8f-0727-45da-a77e-c3907a3d0793	2026-08-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Endometrium Argentum	ENDOMETRIUM ARGENTUM	Uriel Pharmacy Inc	d2d1428a-c8b5-9529-e053-2995a90a2343	2026-08-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
S12 AIRBORNE	ALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEAT	Apex Energetics Inc.	bb0036c3-1e4d-5750-e053-2995a90ae895	2026-08-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Q Skin Science	SUNSCREEN	International Cosmeceuticals, Inc	59e4c3d0-ee4c-2350-e063-6394a90ac9d2	2026-08-25	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO zinc stick(GREEN)	TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE	Guangzhou Haishi Biological Technology Co., Ltd.	59c70c82-f7ff-9a04-e063-6294a90a7b3d	2026-08-24	Warnings	Exact identifier unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01	ZINC OXIDE, TITANIUM DIOXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	59d74e3f-e3fa-a7a9-e063-6294a90a76e5	2026-08-24	Warnings	Exact identifier unii: 15FIX9V2JP
Aging Eye Formula	CINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUM	Nutritional Specialties, Inc.	d5b44f79-5299-4b31-ba45-0e511cdbe17c	2026-08-24	Warnings	Exact identifier unii: ETJ7Z6XBU4
Rohto Optic Glow	NAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOL	The Mentholatum Company	df9c5f7c-96e6-4b2b-b8cb-21a6a3342dff	2026-08-20	Warnings	Exact identifier unii: 6DC9Q167V3 unii: FZ989GH94E
Rohto All-In-One	HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE	The Mentholatum Company	43e690e4-b381-46e3-838c-33aef5bdadde	2026-08-20	Warnings	Exact identifier unii: 3NXW29V3WO
Bio Combination 28	SCHUESSLER SALTS	LDD Bioscience Private Limited	597caf33-5107-9dec-e063-6294a90a5fcd	2026-08-20	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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