Omeprazole

Product NDC: 43353-829
11-digit product format: 433530829
Labeler code: 43353
Product ID: 43353-829_1b00384a-efea-458c-8485-5da3db9d28d6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA075410
Marketing category: ANDA
Marketing start: 2009-01-23
Substance: OMEPRAZOLE
Active strength: 40 mg/1
Pharmacologic classes: Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A075410-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01
A075410-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01
A075410-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075410-001	AB
A075410-002	AB
A075410-003	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	A075410-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075410-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2002-11-01	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075410-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-23	`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	A075410-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075410-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A075410-003	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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Chartwell RX, LLC	10f5502a-2e63-4f2a-a3ba-ddc5bd403051	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	PD-Rx Pharmaceuticals, Inc.	ed9895ae-3d18-434c-8b56-47bccdc8fe6d	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	ad675ef6-5377-b9f2-e053-2995a90a06e9	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	55a1fb3c-f040-2e39-e054-00144ff8d46c	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	NuCare Pharmaceuticals,Inc.	8991d464-7abc-4350-e053-2995a90a4ea7	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	1318a1c1-222d-471a-92d6-3632c82fb999	2024-05-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	18f5a7cc-40d8-4aeb-a601-47bc9024f130	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	Lannett Company, Inc.	92201fb1-4570-42db-8da3-3b8c0e291d32	2023-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	Proficient Rx LP	9786b04f-f827-460b-91bc-c0ac967f95dd	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	4b188d97-f1b3-468d-9818-b8333bf24b5a	2020-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075410 application number: ANDA075410 ndc (product): 43353-829

Additional Listing Data#

Finished product: Yes
Brand name base: Omeprazole
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE	40 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
200329	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
4b188d97-f1b3-468d-9818-b8333bf24b5a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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
43353-829-60	Omeprazole	90 in 1 BOTTLE, PLASTIC	CAPSULE, DELAYED RELEASE	90		3
43353-829-80	Omeprazole	180 in 1 BOTTLE, PLASTIC	CAPSULE, DELAYED RELEASE	180		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-829-60	EA - Each	43353-829	bd1f9a1b-b748-4319-b06e-1f46f02da454	1	2015-05-05
43353-829-80	EA - Each	43353-829	1e33d7dc-f80f-41b4-996d-923d0501ea76	1	2021-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
ALUMINUM CHLOROHYDREX PROPYLENE GLYCOL	INACTIVE INGREDIENT	PGG6VG42HP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-829	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20201218_4b188d97-f1b3-468d-9818-b8333bf24b5a.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
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	4b188d97-f1b3-468d-9818-b8333bf24b5a	3
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	4b188d97-f1b3-468d-9818-b8333bf24b5a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-829-60	43353082960	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43353-829-60)	2013-03-25	0000-00-00	No	No	Current
43353-829-80	43353082980	180 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43353-829-80)	2020-11-11	0000-00-00	No	No	Current