Omeprazole

Product NDC: 55111-157
11-digit product format: 551110157
Labeler code: 55111
Product ID: 55111-157_0dc50704-e0d5-1fcc-b0b5-6e5556db65e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Omeprazole
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Dr. Reddy's Laboratories Limited
Application: ANDA075576
Marketing category: ANDA
Marketing start: 2009-01-21
Substance: OMEPRAZOLE
Active strength: 10 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
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
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 ndc (product): 55111-157
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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OMEPRAZOLE	10 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
72fb11b6-b08c-2f02-d82b-f60f52394903	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	SPL version
55111-157-01	Omeprazole	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	28
55111-157-10	Omeprazole	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	28
55111-157-30	Omeprazole	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	28
55111-157-78	Omeprazole	10 in 1 CARTON	CAPSULE, DELAYED RELEASE	10	28
55111-157-79	Omeprazole	10 in 1 BLISTER PACK	CAPSULE, DELAYED RELEASE	10	28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55111-157-01	EA - Each	55111-157	37e5e28a-3a41-4fdb-b52b-5cfec7144a0d	1	2013-02-13
55111-157-30	EA - Each	55111-157	42a66e55-e390-4cd9-9947-d1298c885999	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Omeprazole	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
omeprazole	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
butyl alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
crospovidone	INACTIVE INGREDIENT	68401960MK	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
D&C Red No. 28	INACTIVE INGREDIENT	767IP0Y5NH	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
FD&C Yellow No. 6	INACTIVE INGREDIENT	H77VEI93A8	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
gelatin	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
mannitol	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
meglumine	INACTIVE INGREDIENT	6HG8UB2MUY	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
methacrylic acid - ethyl acrylate copolymer (1:1) type A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
poloxamer 407	INACTIVE INGREDIENT	TUF2IVW3M2	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
povidone	INACTIVE INGREDIENT	FZ989GH94E	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
shellac	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
triethyl citrate	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	11
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
MEGLUMINE	INACTIVE INGREDIENT	6HG8UB2MUY	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]	3
Omeprazole	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
omeprazole	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
crospovidone	INACTIVE INGREDIENT	68401960MK	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
MEGLUMINE	INACTIVE INGREDIENT	6HG8UB2MUY	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
POLOXAMER 124	INACTIVE INGREDIENT	1S66E28KXA	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	2
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
MEGLUMINE	INACTIVE INGREDIENT	6HG8UB2MUY	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
POLOXAMER 407	INACTIVE INGREDIENT	TUF2IVW3M2	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55111-157	OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]	28	Current NDC, Legacy NDC, 5 package rows	20240608_72fb11b6-b08c-2f02-d82b-f60f52394903.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	72fb11b6-b08c-2f02-d82b-f60f52394903	28
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	72fb11b6-b08c-2f02-d82b-f60f52394903	28
200329	omeprazole 40 MG Delayed Release Oral Capsule	PSN	72fb11b6-b08c-2f02-d82b-f60f52394903	28
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	72fb11b6-b08c-2f02-d82b-f60f52394903	28
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	72fb11b6-b08c-2f02-d82b-f60f52394903	28
200329	omeprazole 40 MG Delayed Release Oral Capsule	SCD	72fb11b6-b08c-2f02-d82b-f60f52394903	28
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	72fb11b6-b08c-2f02-d82b-f60f52394903	28
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	72fb11b6-b08c-2f02-d82b-f60f52394903	28
199119	omeprazole 10 MG Delayed Release Oral Capsule	PSN	f5dcf0b2-4fa2-023a-e053-2995a90a183a	7
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	f5dcf0b2-4fa2-023a-e053-2995a90a183a	7
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	f5dcf0b2-4fa2-023a-e053-2995a90a183a	7
199119	omeprazole 10 MG Delayed Release Oral Capsule	PSN	f0f61a89-700d-481d-9255-6f9a9afa7025	6
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	f0f61a89-700d-481d-9255-6f9a9afa7025	6
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	f0f61a89-700d-481d-9255-6f9a9afa7025	6
199119	omeprazole 10 MG Delayed Release Oral Capsule	PSN	60752a58-1d6c-4b4d-98dd-d49c76d2f443	2
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	60752a58-1d6c-4b4d-98dd-d49c76d2f443	2
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	60752a58-1d6c-4b4d-98dd-d49c76d2f443	2
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	60752a58-1d6c-4b4d-98dd-d49c76d2f443	2
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	60752a58-1d6c-4b4d-98dd-d49c76d2f443	2
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	60752a58-1d6c-4b4d-98dd-d49c76d2f443	2
199119	omeprazole 10 MG Delayed Release Oral Capsule	PSN	9a77cf66-e110-4d51-ae8a-bea6207bba75	1
199119	omeprazole 10 MG Delayed Release Oral Capsule	PSN	a976b80a-6c01-2050-e053-2995a90ac814	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	PSN	9a77cf66-e110-4d51-ae8a-bea6207bba75	1
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	a976b80a-6c01-2050-e053-2995a90ac814	1
199119	omeprazole 10 MG Delayed Release Oral Capsule	SCD	9a77cf66-e110-4d51-ae8a-bea6207bba75	1
198051	omeprazole 20 MG Delayed Release Oral Capsule	SCD	9a77cf66-e110-4d51-ae8a-bea6207bba75	1
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	9a77cf66-e110-4d51-ae8a-bea6207bba75	1
199119	omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral Capsule	SY	a976b80a-6c01-2050-e053-2995a90ac814	1
198051	omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule	SY	9a77cf66-e110-4d51-ae8a-bea6207bba75	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55111-157-01	55111015701	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-157-01)		2009-01-21	0000-00-00	No	No	Current
55111-157-10	55111015710	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-157-10)		2009-01-21	0000-00-00	No	No	Current
55111-157-30	55111015730	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-157-30)		2009-01-21	0000-00-00	No	No	Current
55111-157-78	55111015778	10 BLISTER PACK in 1 CARTON (55111-157-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (55111-157-79)	10 blister pack	2009-01-21	0000-00-00	No	No	Current
55111-157-79	55111015779	10 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Omeprazole	QPharma, Inc. \| Northwind Health Company, LLC	2025-12-01	HUMAN PRESCRIPTION DRUG LABEL	7
Omeprazole	Proficient Rx LP	2024-10-01	HUMAN PRESCRIPTION DRUG LABEL	6
Omeprazole	Dr. Reddy's Laboratories Limited \| Dr. Reddy's Laboratories Limited - FTO III	2024-04-15	HUMAN PRESCRIPTION DRUG LABEL	28
Omeprazole	Bryant Ranch Prepack	2022-06-28	HUMAN PRESCRIPTION DRUG LABEL	15
Omeprazole	Denton Pharma, Inc. dba Northwind Pharmaceuticals	2020-06-08	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	Aidarex Pharmaceuticals LLC	2012-10-04	HUMAN PRESCRIPTION DRUG LABEL	1
Omeprazole	Rebel Distributors Corp	2011-12-27	HUMAN PRESCRIPTION DRUG LABEL	2