Omeprazole

Product NDC: 68084-128
11-digit product format: 680840128
Labeler code: 68084
Product ID: 68084-128_2e5b1ce8-f3a9-3435-e063-6394a90a98ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA075576
Marketing category: ANDA
Marketing start: 2009-10-23
Marketing end: 2026-08-31
Substance: OMEPRAZOLE
Active strength: 20 mg/1
Pharmacologic classes: Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075576-001	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21
A075576-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22
A075576-003	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075576-001	AB
A075576-002	AB
A075576-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A075576-001	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075576-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075576-003	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A075576-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075576-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075576-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	St. Mary's Medical Park Pharmacy	1eb57c13-25ed-70bc-e063-6294a90afdac	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	Northwind Health Company, LLC	aae3bf9f-5d05-889f-e053-2995a90a5ff2	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	QPharma, Inc.	f5dcf0b2-4fa2-023a-e053-2995a90a183a	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	Quallent Pharmaceuticals Health LLC	665e9877-85ac-fdb6-54ac-1c47941ceab8	2025-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	PD-Rx Pharmaceuticals, Inc.	e235ef89-3592-4ca1-8c13-d7ce84b1001c	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	American Health Packaging	a17e415e-a559-4a8d-a455-699184a01523	2025-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576 ndc (product): 68084-128
Omeprazole DR	OMEPRAZOLE	Advanced Rx of Tennessee, LLC	af85e324-ef9f-196c-e053-2995a90a384e	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	Quality Care Products, LLC	581d1c3d-457a-41f2-8db0-5b6219cdcb09	2024-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	Proficient Rx LP	f0f61a89-700d-481d-9255-6f9a9afa7025	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	Advanced Rx of Tennessee, LLC	1d4ecc1e-5180-f75e-e063-6394a90a51a6	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	e1f20429-cfaa-420b-a65a-271be37eb799	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	Dr. Reddy's Laboratories Limited	72fb11b6-b08c-2f02-d82b-f60f52394903	2024-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	A-S Medication Solutions	b129fe93-c8a2-4ae8-ad1b-8f9ae5779b68	2023-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576
Omeprazole	OMEPRAZOLE	NorthStar Rx LLC	c5af5f4b-17be-7245-b281-f27c87831242	2023-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075576 application number: ANDA075576

Additional Listing Data#

Finished product: Yes
Brand name base: Omeprazole

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
KG60484QX9	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198051	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a17e415e-a559-4a8d-a455-699184a01523	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1	Product name	5	20210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823

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 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

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	Current NDC, Legacy NDC, 2 package rows	20250223_a17e415e-a559-4a8d-a455-699184a01523.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
KG60484QX9	OMEPRAZOLE	73590-58-6	OMEPRAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	a17e415e-a559-4a8d-a455-699184a01523	15
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	a17e415e-a559-4a8d-a455-699184a01523	15
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	a17e415e-a559-4a8d-a455-699184a01523	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-128-01	68084012801	100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-128-01) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (68084-128-11)	100 blister pack	2009-10-23	2026-08-31	No	No	Current
68084-128-11	68084012811	1 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole	American Health Packaging	2025-02-17	HUMAN PRESCRIPTION DRUG LABEL	15
Omeprazole	Cardinal Health 107, LLC	2024-09-25	HUMAN PRESCRIPTION DRUG LABEL	14