Application 203154

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALLOPURINOLALLOPURINOLTABLET;ORAL100MGNoNo
002ALLOPURINOLALLOPURINOLTABLET;ORAL300MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203154-001ALLOPURINOLALLOPURINOL100MGTABLET / ORALAB2013-05-06
A203154-002ALLOPURINOLALLOPURINOL300MGTABLET / ORALAB2013-05-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203154-001AB
A203154-002AB

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-06caaa826d4ba7…
2026-08-18 06:07:402026-07A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203154-002ALLOPURINOL300MGTABLET / ORALABRS2013-05-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-06bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203154-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203154-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203154-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203154-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203154-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203154-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203154-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203154-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203154-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203154-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203154-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203154-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203154-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203154-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203154-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203154-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203154-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203154-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203154-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203154-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203154-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203154-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203154-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203154-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203154-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203154-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203154-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203154-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203154-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203154-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203154-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203154-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203154-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203154-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203154-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203154-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203154-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203154-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203154-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203154-002AB1bb7c543d1eb4…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllopurinolALLOPURINOLBryant Ranch Prepack3bcd1381-34d9-4fa5-bfc5-2566cb7a76382026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203154
application number: ANDA203154
AllopurinolALLOPURINOLBryant Ranch Prepack76ed9122-b845-423b-a6d5-a47b317433172026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203154
application number: ANDA203154
ndc (product): 71335-0112
AllopurinolALLOPURINOLPreferred Pharmaceuticals Inc.eb1b1aa6-cbd3-4b06-b9f9-9a0779a2da082026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203154
application number: ANDA203154
ndc (product): 68788-6323
AllopurinolALLOPURINOLNorthwind Health Company, LLCf3198e1b-6344-ad96-e053-2995a90a4aaf2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203154
application number: ANDA203154
AllopurinolALLOPURINOLAccord Healthcare Inc.682dd8b8-fc6e-47c5-95b7-82d7ad96b7502025-10-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203154
application number: ANDA203154
ndc (product): 16729-134
ndc (product): 16729-135
AllopurinolALLOPURINOLAdvanced Rx Pharmacy of Tennessee, LLCec09fbcf-6e20-8438-e053-2a95a90a63762024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203154
application number: ANDA203154
AllopurinolALLOPURINOLNuCare Pharmaceuticals, Inc.44bcc8df-a803-010f-e054-00144ff88e882024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203154
application number: ANDA203154
ndc (product): 66267-665
AllopurinolALLOPURINOLA-S Medication Solutions71accbc4-8bd7-4d22-ae53-c7b044a15ffa2024-04-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203154
application number: ANDA203154
ndc (product): 50090-5168
AllopurinolALLOPURINOLAphena Pharma Solutions - Tennessee, LLC0155151c-6e84-4f9b-9233-60ffa74832932022-11-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203154
application number: ANDA203154
AllopurinolALLOPURINOLProficient Rx LPd94f6643-621f-45ed-b2dc-26f84c5626ae2020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203154
application number: ANDA203154
ndc (product): 71205-049

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 87 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-134AllopurinolallopurinolAccord Healthcare Inc.ANDACurrent
16729-134AllopurinolallopurinolAccord Healthcare Inc.ANDACurrent
16729-134AllopurinolallopurinolAccord Healthcare Inc.ANDACurrent
16729-134AllopurinolallopurinolAccord Healthcare Inc.ANDACurrent
16729-134AllopurinolallopurinolAccord Healthcare Inc.ANDACurrent
16729-135AllopurinolALLOPURINOLAccord Healthcare Inc.ANDACurrent
16729-135AllopurinolALLOPURINOLAccord Healthcare Inc.ANDACurrent
16729-135AllopurinolALLOPURINOLAccord Healthcare Inc.ANDACurrent
16729-135AllopurinolALLOPURINOLAccord Healthcare Inc.ANDACurrent
16729-135AllopurinolALLOPURINOLAccord Healthcare Inc.ANDACurrent
50090-5168AllopurinolallopurinolA-S Medication SolutionsANDACurrent
50090-5168AllopurinolallopurinolA-S Medication SolutionsANDACurrent
50090-5168AllopurinolallopurinolA-S Medication SolutionsANDACurrent
50090-5194AllopurinolALLOPURINOLA-S Medication SolutionsANDACurrent
50090-5194AllopurinolALLOPURINOLA-S Medication SolutionsANDACurrent
55700-935AllopurinolALLOPURINOLQuality Care Products, LLCANDACurrent
55700-935AllopurinolALLOPURINOLQuality Care Products, LLCANDACurrent
55700-947AllopurinolallopurinolQuality Care Products, LLCANDACurrent
55700-947AllopurinolallopurinolQuality Care Products, LLCANDACurrent
60760-134AllopurinolallopurinolSt. Mary's Medical Park PharmacyANDACurrent
60760-134AllopurinolallopurinolSt. Mary's Medical Park PharmacyANDACurrent
60760-139AllopurinolALLOPURINOLSt. Mary's Medical Park PharmacyANDACurrent
60760-139AllopurinolALLOPURINOLSt. Mary's Medical Park PharmacyANDACurrent
61919-471ALLOPURINOLALLOPURINOLDIRECT RXANDACurrent
61919-471ALLOPURINOLALLOPURINOLDirect_RxANDACurrent
61919-471ALLOPURINOLALLOPURINOLDirect_RxANDACurrent
61919-471ALLOPURINOLALLOPURINOLDIRECT RXANDACurrent
61919-471ALLOPURINOLALLOPURINOLDIRECT RXANDACurrent
61919-748ALLOPURINOLALLOPURINOLDIRECT RXANDACurrent
63629-7908AllopurinolallopurinolBryant Ranch PrepackANDACurrent
63629-7908AllopurinolallopurinolBryant Ranch PrepackANDACurrent
63629-7999AllopurinolALLOPURINOLBryant Ranch PrepackANDACurrent
63629-8020AllopurinolallopurinolBryant Ranch PrepackANDACurrent
63629-8020AllopurinolallopurinolBryant Ranch PrepackANDACurrent
63629-8021AllopurinolALLOPURINOLBryant Ranch PrepackANDACurrent
66267-224AllopurinolALLOPURINOLNuCare Pharmaceuticals, Inc.ANDACurrent
66267-224AllopurinolALLOPURINOLNuCare Pharmaceuticals, Inc.ANDACurrent
66267-665AllopurinolallopurinolNuCare Pharmaceuticals, Inc.ANDACurrent
66267-665AllopurinolallopurinolNuCare Pharmaceuticals, Inc.ANDACurrent
66267-665AllopurinolallopurinolNuCare Pharmaceuticals, Inc.ANDACurrent
66267-665AllopurinolallopurinolNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1805AllopurinolallopurinolNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2660AllopurinolallopurinolNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6323AllopurinolALLOPURINOLPreferred Pharmaceuticals Inc.ANDACurrent
68788-6323AllopurinolALLOPURINOLPreferred Pharmaceuticals Inc.ANDACurrent
68788-6323AllopurinolALLOPURINOLPreferred Pharmaceuticals Inc.ANDACurrent
68788-6323AllopurinolALLOPURINOLPreferred Pharmaceuticals Inc.ANDACurrent
68788-7383AllopurinolallopurinolPreferred Pharmaceuticals Inc.ANDACurrent
68788-7383AllopurinolallopurinolPreferred Pharmaceuticals Inc.ANDACurrent
68788-7383AllopurinolallopurinolPreferred Pharmaceuticals Inc.ANDACurrent
68788-7383AllopurinolallopurinolPreferred Pharmaceuticals Inc.ANDACurrent
70518-0451AllopurinolallopurinolREMEDYREPACK INC.ANDACurrent
70518-0451AllopurinolallopurinolREMEDYREPACK INC.ANDACurrent
70518-0451AllopurinolallopurinolREMEDYREPACK INC.ANDACurrent
70518-0451AllopurinolallopurinolREMEDYREPACK INC.ANDACurrent
70518-0451AllopurinolallopurinolREMEDYREPACK INC.ANDACurrent
70518-0451AllopurinolallopurinolREMEDYREPACK INC.ANDACurrent
70518-0451AllopurinolallopurinolREMEDYREPACK INC.ANDACurrent
70518-0451AllopurinolallopurinolREMEDYREPACK INC.ANDACurrent
70518-0451AllopurinolallopurinolREMEDYREPACK INC.ANDACurrent
70518-0451AllopurinolallopurinolREMEDYREPACK INC.ANDACurrent
70518-0451AllopurinolallopurinolREMEDYREPACK INC.ANDACurrent
70518-1806AllopurinolALLOPURINOLREMEDYREPACK INC.ANDACurrent
70518-1806AllopurinolALLOPURINOLREMEDYREPACK INC.ANDACurrent
70518-1806AllopurinolALLOPURINOLREMEDYREPACK INC.ANDACurrent
70518-1806AllopurinolALLOPURINOLREMEDYREPACK INC.ANDACurrent
70518-1806AllopurinolALLOPURINOLREMEDYREPACK INC.ANDACurrent
70518-1806AllopurinolALLOPURINOLREMEDYREPACK INC.ANDACurrent
70934-072AllopurinolallopurinolDenton Pharma, Inc.ANDACurrent
70934-072AllopurinolallopurinolDenton Pharma, Inc.ANDACurrent
70934-072AllopurinolallopurinolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-072AllopurinolallopurinolDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-072AllopurinolallopurinolDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-504AllopurinolALLOPURINOLDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-504AllopurinolALLOPURINOLDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-049AllopurinolALLOPURINOLProficient Rx LPANDACurrent
71205-049AllopurinolALLOPURINOLProficient Rx LPANDACurrent
71205-049AllopurinolALLOPURINOLProficient Rx LPANDACurrent
71335-0112AllopurinolALLOPURINOLBryant Ranch PrepackANDACurrent
71335-0112AllopurinolALLOPURINOLBryant Ranch PrepackANDACurrent