Application 206999

Type
ANDA
Sponsor
ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENCAPSULE;ORALEQ 200MG FREE ACID AND POTASSIUM SALTNoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206999-001IBUPROFENIBUPROFENEQ 200MG FREE ACID AND POTASSIUM SALTCAPSULE / ORAL2017-12-21

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENRite Aid Corporation47657d95-4a54-49c2-8273-86b413b8f41e2025-07-30WarningsExact identifier
Dolex FlexIBUPROFENPharmadel LLC822d9def-504c-9beb-e053-2991aa0a280e2023-09-13WarningsExact identifier
IbuprofenIBUPROFENCostco Wholesaleeb62ed66-cafd-4d09-acc9-b9abf748ba852022-10-11WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Allergy alert : Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning : This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery Ask a doctor before use if the stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke you are taking a diuretic Ask a doctor or pharmacist before use if you are under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin taking any other drug When using this product take with food or milk if stomach upset occurs Stop use and ask a doctor if you experience any of the following signs of stomach bleeding: feel faint have bloody or black stools vomit blood have stomach pain that does not get better you have symptoms of heart problems or stroke: chest pain slurred speech trouble breathing leg swelling weaknessin one part or side of body pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present in the painful area any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely dir...

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11673-850IbuprofenIbuprofenTARGET CorporationANDACurrent
11673-850IbuprofenIbuprofenTARGET CorporationANDACurrent
11673-850IbuprofenIbuprofenTARGET CorporationANDACurrent
11822-0894IbuprofenIbuprofenRite Aid CorporationANDACurrent
21130-749IbuprofenIbuprofenSafeway, Inc.ANDACurrent
21130-749IbuprofenIbuprofenSafeway, Inc.ANDACurrent
21130-749IbuprofenIbuprofenSafeway, Inc.ANDACurrent
30142-750IbuprofenIbuprofenThe Kroger Co.ANDACurrent
30142-750IbuprofenIbuprofenThe Kroger Co.ANDACurrent
30142-750IbuprofenIbuprofenThe Kroger Co.ANDACurrent
37808-750IbuprofenIbuprofenH E BANDACurrent
37808-750IbuprofenIbuprofenH E BANDACurrent
37808-750IbuprofenIbuprofenH E BANDACurrent
41250-752IbuprofenIbuprofenMEIJER, INC.ANDACurrent
41250-752IbuprofenIbuprofenMEIJER, INC.ANDACurrent
41250-752IbuprofenIbuprofenMEIJER, INC.ANDACurrent
49035-865IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-865IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ANDACurrent
49035-865IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-865IbuprofenIbuprofenEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
50594-146IbuprofenIbuprofenBIG LOTS STORES, INC.ANDACurrent
50594-146IbuprofenIbuprofenBIG LOTS STORES, INC.ANDACurrent
50804-750IbuprofenIbuprofenGood Sense (Geiss, Destin & Dunn, Inc.)ANDACurrent
50804-750IbuprofenIbuprofenGood Sense (Geiss, Destin & Dunn, Inc.)ANDACurrent
50804-750IbuprofenIbuprofenGood Sense (Geiss, Destin & Dunn, Inc.)ANDACurrent
55319-750IbuprofenIbuprofenFamily Dollar (FAMILY WELLNESS)ANDACurrent
55319-750IbuprofenIbuprofenFamily Dollar (FAMILY WELLNESS)ANDACurrent
55319-750IbuprofenIbuprofenFamily Dollar (FAMILY WELLNESS)ANDACurrent
55319-750IbuprofenIbuprofenFamily Dollar (FAMILY WELLNESS)ANDACurrent
55758-310Dolex FlexIbuprofenPharmadel LLCANDACurrent
55758-310Dolex FlexIbuprofenPharmadel LLCANDACurrent
55910-651IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-651IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-651IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-750IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-750IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-750IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
55910-750IbuprofenIbuprofenDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ANDACurrent
63981-750IbuprofenIbuprofenCostco WholesaleANDACurrent
63981-750IbuprofenIbuprofenCostco WholesaleANDACurrent
63981-750IbuprofenIbuprofenCostco WholesaleANDACurrent
69230-146IbuprofenIbuprofenCamber Consumer Care. Inc.ANDACurrent
69842-851IbuprofenIbuprofenCVS PharmacyANDACurrent
69842-851IbuprofenIbuprofenCVS PharmacyANDACurrent
69842-851IbuprofenIbuprofenCVS PharmacyANDACurrent
72865-132IbuprofenIbuprofenXLCare Pharmaceuticals, IncANDACurrent