Omeprazole

Product NDC: 60505-0146
11-digit product format: 605050146
Labeler code: 60505
Product ID: 60505-0146_8619e520-d106-4778-e92a-09b919b55c70
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Apotex Corp
Application: ANDA076048
Marketing category: ANDA
Marketing start: 2009-01-21
Marketing end: 2027-01-31
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
Current FDA listing: Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60505-0146	60505-0146-0	D	Discontinued by firm		2026-07-31
excluded package	package	60505-0146	60505-0146-9	D	Discontinued by firm		2026-07-31

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
A076048-001	OMEPRAZOLE	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22
A076048-002	OMEPRAZOLE	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22
A076048-003	OMEPRAZOLE	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076048-001	AB
A076048-002	AB
A076048-003	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	A076048-001	OMEPRAZOLE	10MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076048-002	OMEPRAZOLE	20MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2007-10-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076048-003	OMEPRAZOLE	40MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2009-01-21	`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	A076048-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076048-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076048-003	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	1249c42d-6358-48b3-8fe0-10333c7f501d	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076048 application number: ANDA076048
Omeprazole	OMEPRAZOLE	Bryant Ranch Prepack	44349466-73ea-4053-8ff6-5b4b7372c9cd	2024-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076048 application number: ANDA076048
Omeprazole	OMEPRAZOLE	Proficient Rx LP	03ac077f-3873-4087-96d0-89049161dea9	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076048 application number: ANDA076048
Omeprazole	OMEPRAZOLE	Proficient Rx LP	253451a6-02a9-4b27-aed7-f3dbc2e09682	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076048 application number: ANDA076048
Omeprazole	OMEPRAZOLE	Apotex Corp	b83329ac-a65e-b3af-a3fb-c5a6c740e5e7	2024-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076048 application number: ANDA076048 ndc (product): 60505-0146
Omeprazole	OMEPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	a0dc4ffa-db18-4871-9d36-51d02e3b2bd9	2019-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076048 application number: ANDA076048

Additional Listing Data#

Finished product: Yes
Brand name base: Omeprazole

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198051	Internal RxNorm lookup
199119	Internal RxNorm lookup
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
b83329ac-a65e-b3af-a3fb-c5a6c740e5e7	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60505-0146-0	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	35
60505-0146-1	Omeprazole	500 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	500	35
60505-0146-2	Omeprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	35
60505-0146-9	Omeprazole	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-0146-0	EA - Each	60505-0146	33b75d5f-a580-47ce-83f9-2f43593d28af	1	2012-07-24
60505-0146-1	EA - Each	60505-0146	140ecd10-0a3c-490d-80fd-8de6b9a86489	1	2012-07-24
60505-0146-2	EA - Each	60505-0146	70ea9f18-24b9-4279-83bf-8bf5f46d9766	1	2012-07-24
60505-0146-9	EA - Each	60505-0146	048b48cd-bc16-4e15-9114-e3520224eb0b	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 [APOTEX CORP]	15
Omeprazole	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]	15
Omeprazole	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
Omeprazole	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]	15
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]	15
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]	15
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]	15
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]	15
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]	15
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]	15
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]	15
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]	15
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]	15
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]	15
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]	15
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]	15
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]	15
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]	15
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AVERA MCKENNAN HOSPITAL]	15
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	15
Omeprazole	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	11
Omeprazole	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	11
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	11
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	11
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	11
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	11
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	11
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	11
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	11
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	11
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	11
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	11
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	11
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	11
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	11
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	11
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	11
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
Omeprazole	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BLENHEIM PHARMACAL, INC.]	4
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS, INC.]	4
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]	2
Omeprazole	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]	1
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]	1
Omeprazole	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
Omeprazole	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]	1
Omeprazole	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]	1
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]	1
MAGNESIUM HYDROXIDE	INACTIVE INGREDIENT	NBZ3QY004S	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-0146	OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]	35	Current NDC, Legacy NDC, 4 package rows	20240423_b83329ac-a65e-b3af-a3fb-c5a6c740e5e7.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
199119	omeprazole 10 MG Delayed Release Oral Capsule	PSN	b83329ac-a65e-b3af-a3fb-c5a6c740e5e7	35
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	b83329ac-a65e-b3af-a3fb-c5a6c740e5e7	35
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	b83329ac-a65e-b3af-a3fb-c5a6c740e5e7	35
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	b83329ac-a65e-b3af-a3fb-c5a6c740e5e7	35
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	b83329ac-a65e-b3af-a3fb-c5a6c740e5e7	35
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	b83329ac-a65e-b3af-a3fb-c5a6c740e5e7	35
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	b83329ac-a65e-b3af-a3fb-c5a6c740e5e7	35
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	b83329ac-a65e-b3af-a3fb-c5a6c740e5e7	35
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	03367fd2-bf06-47f7-8a69-8f90a0b81734	15
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	03367fd2-bf06-47f7-8a69-8f90a0b81734	15
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	c6bc8fb7-2862-464a-b7c9-e409034f072a	14
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	c6bc8fb7-2862-464a-b7c9-e409034f072a	14
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	c6bc8fb7-2862-464a-b7c9-e409034f072a	14
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	c6bc8fb7-2862-464a-b7c9-e409034f072a	14
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	c6bc8fb7-2862-464a-b7c9-e409034f072a	14
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	253451a6-02a9-4b27-aed7-f3dbc2e09682	6
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	253451a6-02a9-4b27-aed7-f3dbc2e09682	6
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	44349466-73ea-4053-8ff6-5b4b7372c9cd	5
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	44349466-73ea-4053-8ff6-5b4b7372c9cd	5
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	b6e75ecc-4332-4bfc-8a77-4721178ebcca	5
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	44349466-73ea-4053-8ff6-5b4b7372c9cd	5
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	44349466-73ea-4053-8ff6-5b4b7372c9cd	5
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	b6e75ecc-4332-4bfc-8a77-4721178ebcca	5
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	44349466-73ea-4053-8ff6-5b4b7372c9cd	5
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	0f560bc9-9f40-0f96-e054-00144ff88e88	4
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	0f560bc9-9f40-0f96-e054-00144ff88e88	4
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	0f560bc9-9f40-0f96-e054-00144ff88e88	4
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	0f560bc9-9f40-0f96-e054-00144ff88e88	4
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	0f560bc9-9f40-0f96-e054-00144ff88e88	4
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	a0dc4ffa-db18-4871-9d36-51d02e3b2bd9	1
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	a0dc4ffa-db18-4871-9d36-51d02e3b2bd9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-0146-0	60505014600	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0146-0)	2009-01-21	0000-00-00	No	No	Current
60505-0146-1	60505014601	500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0146-1)	2009-01-21	2027-01-31	No	No	Current
60505-0146-2	60505014602	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0146-2)	2009-01-21	2027-01-31	No	No	Current
60505-0146-9	60505014609	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0146-9)	2009-01-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole	Bryant Ranch Prepack	2024-10-03	HUMAN PRESCRIPTION DRUG LABEL	5
Omeprazole	Proficient Rx LP	2024-10-01	HUMAN PRESCRIPTION DRUG LABEL	6
Omeprazole	Apotex Corp \| Apotex Inc.	2024-04-22	HUMAN PRESCRIPTION DRUG LABEL	35
OMEPRAZOLE DR	Direct Rx	2023-05-31	HUMAN PRESCRIPTION DRUG LABEL	14
Omeprazole	AvKARE	2022-01-13	HUMAN PRESCRIPTION DRUG LABEL	3
Omeprazole	PD-Rx Pharmaceuticals, Inc.	2021-08-13	HUMAN PRESCRIPTION DRUG LABEL	22
Omeprazole	Aphena Pharma Solutions - Tennessee, LLC	2019-03-20	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	Preferred Pharmaceuticals, Inc.	2019-02-06	HUMAN PRESCRIPTION DRUG LABEL	7
Omeprazole	Golden State Medical Supply, Inc.	2018-12-19	HUMAN PRESCRIPTION DRUG LABEL	3
Omeprazole	Unit Dose Services	2017-07-01	HUMAN PRESCRIPTION DRUG LABEL	5
Omeprazole	NuCare Pharmaceuticals, Inc.	2017-02-20	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	Blenheim Pharmacal, Inc.	2015-04-10	HUMAN PRESCRIPTION DRUG LABEL	4
OMEPRAZOLE	Northwind Pharmaceuticals, LLC	2015-03-25	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	Avera McKennan Hospital	2015-01-16	HUMAN PRESCRIPTION DRUG LABEL	15