FDA.reportPublic FDA data

Omeprazole

Product NDC
43063-549
11-digit product format
430630549
Labeler code
43063
Product ID
43063-549_db747126-77d4-2e1d-e053-2a95a90a2d30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA075576
Marketing category
ANDA
Marketing start
2009-01-21
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43063-549DDiscontinued by firm2026-07-31
excluded packagepackage43063-54943063-549-90DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075576-001OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21
A075576-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22
A075576-003OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22

Therapeutic equivalence codes#

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

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

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075576-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21a50c72e98297…
2026-08-01 22:54:322026-06A075576-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22a50c72e98297…
2026-08-01 22:54:322026-06A075576-003OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2007-10-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075576-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075576-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A075576-003AB1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLESt. Mary's Medical Park Pharmacy1eb57c13-25ed-70bc-e063-6294a90afdac2026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLENorthwind Health Company, LLCaae3bf9f-5d05-889f-e053-2995a90a5ff22025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEQPharma, Inc.f5dcf0b2-4fa2-023a-e053-2995a90a183a2025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEQuallent Pharmaceuticals Health LLC665e9877-85ac-fdb6-54ac-1c47941ceab82025-11-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEPD-Rx Pharmaceuticals, Inc.e235ef89-3592-4ca1-8c13-d7ce84b1001c2025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEAmerican Health Packaginga17e415e-a559-4a8d-a455-699184a015232025-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
Omeprazole DROMEPRAZOLEAdvanced Rx of Tennessee, LLCaf85e324-ef9f-196c-e053-2995a90a384e2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEQuality Care Products, LLC581d1c3d-457a-41f2-8db0-5b6219cdcb092024-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEProficient Rx LPf0f61a89-700d-481d-9255-6f9a9afa70252024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEAdvanced Rx of Tennessee, LLC1d4ecc1e-5180-f75e-e063-6394a90a51a62024-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEBryant Ranch Prepacke1f20429-cfaa-420b-a65a-271be37eb7992024-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEDr. Reddy's Laboratories Limited72fb11b6-b08c-2f02-d82b-f60f523949032024-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLEA-S Medication Solutionsb129fe93-c8a2-4ae8-ad1b-8f9ae5779b682023-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576
OmeprazoleOMEPRAZOLENorthStar Rx LLCc5af5f4b-17be-7245-b281-f27c878312422023-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075576
application number: ANDA075576

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-549-90EA - Each43063-5493ed8c548-26f6-4dfd-ac50-e30bd279902912015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OmeprazoleACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
omeprazoleACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
crospovidoneINACTIVE INGREDIENT68401960MKOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
gelatinINACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
hypromellosesINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
magnesium stearateINACTIVE INGREDIENT70097M6I30OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
mannitolINACTIVE INGREDIENT3OWL53L36AOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
meglumineINACTIVE INGREDIENT6HG8UB2MUYOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
methacrylic acid - ethyl acrylate copolymer (1:1) type AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
poloxamer 407INACTIVE INGREDIENTTUF2IVW3M2OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
povidoneINACTIVE INGREDIENTFZ989GH94EOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
propylene glycolINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
shellacINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-549-904306305499090 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-549-90) 2014-11-240000-00-00NoNoCurrent