Application 090549

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMTABLET;ORALEQ 250MG BASENoNo
002PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMTABLET;ORALEQ 500MG BASENoNo

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

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
A090549-001PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11
A090549-002PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090549-001AB
A090549-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090549-001PENICILLIN V POTASSIUMEQ 250MG BASETABLET / ORALAB2013-10-11782e0a99824c…
2021-12-28 21:50 UTC2021-12A090549-002PENICILLIN V POTASSIUMEQ 500MG BASETABLET / ORALAB2013-10-11782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090549-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090549-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090549-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090549-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090549-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090549-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090549-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090549-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090549-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090549-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090549-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090549-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090549-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090549-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090549-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090549-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090549-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090549-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090549-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090549-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090549-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090549-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090549-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090549-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090549-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090549-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090549-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090549-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090549-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090549-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090549-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090549-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090549-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090549-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090549-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090549-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090549-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090549-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090549-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090549-002AB1782e0a99824c…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Penicillin V PotassiumPENICILLIN V POTASSIUMREMEDYREPACK INC.5f0759cc-c553-49b9-9049-80e7137589582026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
ndc (product): 70518-3441
Penicillin V PotassiumPENICILLIN V POTASSIUMBryant Ranch Prepack609c3e26-9220-4f3c-b393-a2b41b68de6c2026-03-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.ceddc406-4a17-471f-917e-63b4b03779ea2025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
ndc (product): 43063-995
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.a251a769-280e-4024-ad7a-3177463258182025-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMBryant Ranch Prepackbdffe8fe-e6e0-4c08-894c-0653605ff4332025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMPreferred Pharmaceuticals Inc.56192625-0564-4131-94b2-8b9c6a0b53b02025-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
ndc (product): 68788-8242
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.8d98ea77-f237-4b93-87fa-41f556436ab52025-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
ndc (product): 72789-245
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.7aef4c8b-aee7-453d-bb6f-fce8e4588e3b2025-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
ndc (product): 72789-223
ndc (product): 72789-222
Penicillin V PotassiumPENICILLIN V POTASSIUMNuCare Pharmaceuticals,Inc.fbd3f219-d052-fd00-e053-6294a90a66ac2025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
Penicillin V PotassiumPENICILLIN V POTASSIUMPD-Rx Pharmaceuticals, Inc.f3f5947d-0dd3-4b50-93a2-bc83251809782025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
ndc (product): 43063-780
Penicillin V PotassiumPENICILLIN V POTASSIUMA-S Medication Solutions93c1177c-35da-464b-be90-bb18fe9bd27d2024-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
ndc (product): 50090-3374
Penicillin V PotassiumPENICILLIN V POTASSIUMHikma Pharmaceuticals USA Inc.dc33f7a4-348b-4b4c-a5f2-c4f908fda4aa2024-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
ndc (product): 0143-9837
ndc (product): 0143-9836
Penicillin V PotassiumPENICILLIN V POTASSIUMA-S Medication Solutionse4642fb3-2db9-49d3-8fd4-ceb750f704372023-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090549
application number: ANDA090549
ndc (product): 50090-3210
ndc (product): 50090-3307

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9836Penicillin V PotassiumPenicillin V PotassiumHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9836Penicillin V PotassiumPenicillin V PotassiumHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9836Penicillin V PotassiumPenicillin V PotassiumWest-Ward Pharmaceuticals CorpANDACurrent
0143-9837Penicillin V PotassiumPenicillin V PotassiumHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9837Penicillin V PotassiumPenicillin V PotassiumHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9837Penicillin V PotassiumPenicillin V PotassiumWest-Ward Pharmaceuticals CorpANDACurrent
43063-780Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-780Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-780Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-780Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-780Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-780Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-780Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-780Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-995Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-995Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-995Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-995Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-995Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-3210Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-3210Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-3210Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-3210Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-3210Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-3307Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-3307Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-3374Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-3374Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-3837Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
55700-572Penicillin V PotassiumPenicillin V PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-572Penicillin V PotassiumPenicillin V PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-572Penicillin V PotassiumPenicillin V PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
59115-117Penicillin V PotassiumPenicillin V PotassiumHikma PharmaceuticalANDACurrent
59115-117Penicillin V PotassiumPenicillin V PotassiumHikma PharmaceuticalANDACurrent
59115-118Penicillin V PotassiumPenicillin V PotassiumHikma PharmaceuticalANDACurrent
59115-118Penicillin V PotassiumPenicillin V PotassiumHikma PharmaceuticalANDACurrent
68071-2457Penicillin V PotassiumPenicillin V PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2515Penicillin V PotassiumPenicillin V PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2778Penicillin V PotassiumPenicillin V PotassiumNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7136Penicillin V PotassiumPenicillin V PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7136Penicillin V PotassiumPenicillin V PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7136Penicillin V PotassiumPenicillin V PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7136Penicillin V PotassiumPenicillin V PotassiumPreferred Pharmaceuticals, Inc.ANDACurrent
68788-8242Penicillin V PotassiumPenicillin V PotassiumPreferred Pharmaceuticals Inc.ANDACurrent
70518-3441Penicillin V PotassiumPenicillin V PotassiumREMEDYREPACK INC.ANDACurrent
70518-3535Penicillin V PotassiumPenicillin V PotassiumREMEDYREPACK INC.ANDACurrent
72789-222Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-222Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-223Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-245Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent