FDA.reportPublic FDA data

Application 202413

Type
ANDA
Sponsor
SHANDONG XINHUA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL400MGNoNo
002IBUPROFENIBUPROFENTABLET;ORAL600MGNoNo
003IBUPROFENIBUPROFENTABLET;ORAL800MGNoNo
004IBUPROFENIBUPROFENTABLET;ORAL300MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202413-001IBUPROFENIBUPROFEN400MGTABLET / ORALAB2016-11-23
A202413-002IBUPROFENIBUPROFEN600MGTABLET / ORALAB2016-11-23
A202413-003IBUPROFENIBUPROFEN800MGTABLET / ORALAB2016-11-23
A202413-004IBUPROFENIBUPROFEN300MGTABLET / ORAL2024-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202413-001AB
A202413-002AB
A202413-003AB

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 22:54:322026-06A202413-001IBUPROFEN400MGTABLET / ORALAB2016-11-23a50c72e98297…
2026-08-01 22:54:322026-06A202413-002IBUPROFEN600MGTABLET / ORALAB2016-11-23a50c72e98297…
2026-08-01 22:54:322026-06A202413-003IBUPROFEN800MGTABLET / ORALAB2016-11-23a50c72e98297…
2026-08-01 22:54:322026-06A202413-004IBUPROFEN300MGTABLET / ORAL2024-07-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202413-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A202413-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A202413-003AB1a50c72e98297…

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 3 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENREMEDYREPACK INC.2572ed69-d5a7-4513-a202-aca3230e7ec52026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
ndc (product): 70518-2902
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.656658cc-8cf0-42b6-af4f-4e3ab76486252026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.c0156053-add5-4bd5-b89f-f90df2e73be42026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.3a38add6-a114-4e18-836c-3bfc727db2312026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENRedpharm Drug5302291e-4816-8495-e063-6394a90a9cc02026-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENREMEDYREPACK INC.404df13d-4ada-4324-9eed-e21f5d5043a42026-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENST. MARY'S MEDICAL PARK PHARMACY4e67aef4-c3ac-232a-e063-6394a90a3a852026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENBryant Ranch Prepack886c974c-0d32-4a1b-8f54-40c2c12efa452026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.2e0f74a5-b8f3-fc81-e063-6394a90a647a2026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENProficient Rx LPab2f1a30-611b-41b6-9baf-6a82305da8452026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.4b34b58b-2cf7-9aa8-e063-6294a90a06582026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENA-S Medication Solutions0170876a-d8cd-4a2d-8397-db2acdf72ffb2026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.70e191ef-8fad-49eb-9850-fceea119e92f2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.b84ea215-e61d-4c00-8a34-d47c4080779b2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENCoupler LLC4831785a-cde2-79a2-e063-6294a90a9a402026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENAiPing Pharmaceutical, Inc.3e131710-2579-446e-8076-f602ecea813f2026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
ndc (product): 11788-010
ndc (product): 11788-009
ndc (product): 11788-008
IbuprofenIBUPROFENChartwell RX, LLC39f2664f-6c0a-4726-85d7-4227530d4a492025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
ndc (product): 62135-401
ndc (product): 62135-400
ndc (product): 62135-402
IbuprofenIBUPROFENRedpharm Drug44f278ac-6bf9-6aef-e063-6394a90a0bb62025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENRedpharm Drug44f5743f-8c98-dc4d-e063-6294a90a6dfa2025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413
IbuprofenIBUPROFENRedpharm Drug44f609dd-c868-493f-e063-6294a90a71382025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202413
application number: ANDA202413

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 71 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11788-008ibuprofenibuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-008ibuprofenibuprofenAiPing Pharmaceutical Inc.ANDACurrent
11788-008ibuprofenibuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-008ibuprofenibuprofenAiPing Pharmaceutical Inc.ANDACurrent
11788-008ibuprofenibuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-008ibuprofenibuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-008ibuprofenibuprofenAiPing Pharmaceutical Inc.ANDACurrent
11788-008ibuprofenibuprofenAiPing Pharmaceutical Inc.ANDACurrent
11788-008ibuprofenibuprofenAiPing Pharmaceutical Inc.ANDACurrent
11788-008ibuprofenibuprofenAiPing Pharmaceutical Inc.ANDACurrent
11788-009ibuprofenibuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-009ibuprofenibuprofenAiPing Pharmaceutical Inc.ANDACurrent
11788-009ibuprofenibuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-009ibuprofenibuprofenAiPing Pharmaceutical Inc.ANDACurrent
11788-009ibuprofenibuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-009ibuprofenibuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-009ibuprofenibuprofenAiPing Pharmaceutical Inc.ANDACurrent
11788-009ibuprofenibuprofenAiPing Pharmaceutical Inc.ANDACurrent
11788-009ibuprofenibuprofenAiPing Pharmaceutical Inc.ANDACurrent
11788-009ibuprofenibuprofenAiPing Pharmaceutical Inc.ANDACurrent
11788-010ibuprofenibuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-010ibuprofenibuprofenAiPing Pharmaceutical Inc.ANDACurrent
11788-010ibuprofenibuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-010ibuprofenibuprofenAiPing Pharmaceutical Inc.ANDACurrent
11788-010ibuprofenibuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-010ibuprofenibuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-010ibuprofenibuprofenAiPing Pharmaceutical Inc.ANDACurrent
11788-010ibuprofenibuprofenAiPing Pharmaceutical Inc.ANDACurrent
11788-010ibuprofenibuprofenAiPing Pharmaceutical Inc.ANDACurrent
11788-010ibuprofenibuprofenAiPing Pharmaceutical Inc.ANDACurrent
50090-4228IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
50090-4230IbuprofenIbuprofenA-S Medication SolutionsANDACurrent
51293-843ibuprofenibuprofenECI PHARMACEUTICALS LLCANDACurrent
51293-843ibuprofenibuprofenECI PHARMACEUTICALS LLCANDACurrent
51293-844ibuprofenibuprofenECI PHARMACEUTICALS LLCANDACurrent
51293-844ibuprofenibuprofenECI PHARMACEUTICALS LLCANDACurrent
51293-845ibuprofenibuprofenECI PHARMACEUTICALS LLCANDACurrent
51293-845ibuprofenibuprofenECI PHARMACEUTICALS LLCANDACurrent
55700-633IbuprofenIbuprofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-633IbuprofenIbuprofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-634IbuprofenIbuprofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-634IbuprofenIbuprofenLake Erie Medical DBA Quality Care Products LLCANDACurrent
58657-680IbuprofenIbuprofenMethod Pharmaceuticals, LLCANDACurrent
58657-680IbuprofenIbuprofenMethod Pharmaceuticals, LLCANDACurrent
58657-681IbuprofenIbuprofenMethod Pharmaceuticals, LLCANDACurrent
58657-681IbuprofenIbuprofenMethod Pharmaceuticals, LLCANDACurrent
58657-682IbuprofenIbuprofenMethod Pharmaceuticals, LLCANDACurrent
58657-682IbuprofenIbuprofenMethod Pharmaceuticals, LLCANDACurrent
62135-400IbuprofenIbuprofenChartwell RX, LLCANDACurrent
62135-400IbuprofenIbuprofenChartwell RX, LLCANDACurrent
62135-401IbuprofenIbuprofenChartwell RX, LLCANDACurrent
62135-401IbuprofenIbuprofenChartwell RX, LLCANDACurrent
62135-402IbuprofenIbuprofenChartwell RX, LLCANDACurrent
62135-402IbuprofenIbuprofenChartwell RX, LLCANDACurrent
67296-1573IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent
67296-1573IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent
67296-1633IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent
67296-1633IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent
67296-1634IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent
67296-1634IbuprofenIbuprofenRedPharm Drug, Inc.ANDACurrent
68788-8182ibuprofenibuprofenPreferred Pharmaceuticals Inc.ANDACurrent
68788-8183ibuprofenibuprofenPreferred Pharmaceuticals Inc.ANDACurrent
70518-2902ibuprofenibuprofenREMEDYREPACK INC.ANDACurrent
70518-2902ibuprofenibuprofenREMEDYREPACK INC.ANDACurrent
70518-3016ibuprofenibuprofenREMEDYREPACK INC.ANDACurrent
71335-1177IbuprofenIbuprofenBryant Ranch PrepackANDACurrent
71610-456ibuprofenibuprofenAphena Pharma Solutions - Tennessee, LLCANDACurrent
71862-003IbuprofenIbuprofenLandmark Supply Inc.ANDACurrent
71862-003IbuprofenIbuprofenLandmark Supply Inc.ANDACurrent
71862-007IbuprofenIbuprofenLandmark Supply Inc.ANDACurrent
71862-007IbuprofenIbuprofenLandmark Supply Inc.ANDACurrent