Application 062286

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOXACILLIN SODIUMDICLOXACILLIN SODIUMCAPSULE;ORALEQ 250MG BASENoNo
002DICLOXACILLIN SODIUMDICLOXACILLIN SODIUMCAPSULE;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
A062286-001DICLOXACILLIN SODIUMDICLOXACILLIN SODIUMEQ 250MG BASECAPSULE / ORALAB1982-06-03
A062286-002DICLOXACILLIN SODIUMDICLOXACILLIN SODIUMEQ 500MG BASECAPSULE / ORALABRS1982-06-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062286-001AB
A062286-002AB

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 UTC2026-02A062286-001DICLOXACILLIN SODIUMEQ 250MG BASECAPSULE / ORALAB1982-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062286-002DICLOXACILLIN SODIUMEQ 500MG BASECAPSULE / ORALABRS1982-06-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062286-001DICLOXACILLIN SODIUMEQ 250MG BASECAPSULE / ORALAB1982-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062286-002DICLOXACILLIN SODIUMEQ 500MG BASECAPSULE / ORALABRS1982-06-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A062286-001DICLOXACILLIN SODIUMEQ 250MG BASECAPSULE / ORALAB1982-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062286-002DICLOXACILLIN SODIUMEQ 500MG BASECAPSULE / ORALABRS1982-06-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062286-001DICLOXACILLIN SODIUMEQ 250MG BASECAPSULE / ORALAB1982-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062286-002DICLOXACILLIN SODIUMEQ 500MG BASECAPSULE / ORALABRS1982-06-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062286-001DICLOXACILLIN SODIUMEQ 250MG BASECAPSULE / ORALAB1982-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062286-002DICLOXACILLIN SODIUMEQ 500MG BASECAPSULE / ORALABRS1982-06-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062286-001DICLOXACILLIN SODIUMEQ 250MG BASECAPSULE / ORALAB1982-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062286-002DICLOXACILLIN SODIUMEQ 500MG BASECAPSULE / ORALABRS1982-06-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062286-001DICLOXACILLIN SODIUMEQ 250MG BASECAPSULE / ORALAB1982-06-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062286-002DICLOXACILLIN SODIUMEQ 500MG BASECAPSULE / ORALABRS1982-06-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062286-001DICLOXACILLIN SODIUMEQ 250MG BASECAPSULE / ORALAB1982-06-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062286-002DICLOXACILLIN SODIUMEQ 500MG BASECAPSULE / ORALABRS1982-06-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062286-001DICLOXACILLIN SODIUMEQ 250MG BASECAPSULE / ORALAB1982-06-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062286-002DICLOXACILLIN SODIUMEQ 500MG BASECAPSULE / ORALABRS1982-06-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062286-001DICLOXACILLIN SODIUMEQ 250MG BASECAPSULE / ORALAB1982-06-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A062286-002DICLOXACILLIN SODIUMEQ 500MG BASECAPSULE / ORALABRS1982-06-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062286-001DICLOXACILLIN SODIUMEQ 250MG BASECAPSULE / ORALAB1982-06-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062286-002DICLOXACILLIN SODIUMEQ 500MG BASECAPSULE / ORALABRS1982-06-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062286-001DICLOXACILLIN SODIUMEQ 250MG BASECAPSULE / ORALAB1982-06-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062286-002DICLOXACILLIN SODIUMEQ 500MG BASECAPSULE / ORALABRS1982-06-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062286-001DICLOXACILLIN SODIUMEQ 250MG BASECAPSULE / ORALAB1982-06-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062286-002DICLOXACILLIN SODIUMEQ 500MG BASECAPSULE / ORALABRS1982-06-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062286-001DICLOXACILLIN SODIUMEQ 250MG BASECAPSULE / ORALAB1982-06-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062286-002DICLOXACILLIN SODIUMEQ 500MG BASECAPSULE / ORALABRS1982-06-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062286-001DICLOXACILLIN SODIUMEQ 250MG BASECAPSULE / ORAL1982-06-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062286-002DICLOXACILLIN SODIUMEQ 500MG BASECAPSULE / ORALRS1982-06-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062286-001DICLOXACILLIN SODIUMEQ 250MG BASECAPSULE / ORAL1982-06-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062286-002DICLOXACILLIN SODIUMEQ 500MG BASECAPSULE / ORALRS1982-06-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062286-001DICLOXACILLIN SODIUMEQ 250MG BASECAPSULE / ORAL1982-06-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062286-002DICLOXACILLIN SODIUMEQ 500MG BASECAPSULE / ORALRS1982-06-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062286-001DICLOXACILLIN SODIUMEQ 250MG BASECAPSULE / ORALAB1982-06-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062286-002DICLOXACILLIN SODIUMEQ 500MG BASECAPSULE / ORALAB1982-06-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062286-001DICLOXACILLIN SODIUMEQ 250MG BASECAPSULE / ORAL1982-06-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062286-002DICLOXACILLIN SODIUMEQ 500MG BASECAPSULE / ORALRS1982-06-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062286-001DICLOXACILLIN SODIUMEQ 250MG BASECAPSULE / ORAL1982-06-03782e0a99824c…
2021-12-28 21:50 UTC2021-12A062286-002DICLOXACILLIN SODIUMEQ 500MG BASECAPSULE / ORALRS1982-06-03782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A062286-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062286-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062286-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062286-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062286-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062286-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062286-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062286-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062286-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062286-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062286-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062286-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062286-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062286-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062286-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062286-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062286-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062286-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062286-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062286-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062286-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062286-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062286-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062286-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062286-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062286-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062286-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062286-002AB18072bd15b7f6…
2019-12-13 00:20 UTC2019-12A062286-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062286-002AB174a2ff9319b5…
2020-12-22 03:56 UTC2020-12A062286-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A062286-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062286-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A062286-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062286-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A062286-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A062286-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A062286-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A062286-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A062286-002AB1ea99ee380514…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DICLOXACILLIN SODIUMDICLOXACILLIN SODIUMChartwell RX, LLC270c0839-c30c-475d-a505-e70855652c9e2026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062286
application number: ANDA062286
Dicloxacillin SodiumDICLOXACILLIN SODIUMPD-Rx Pharmaceuticals, Inc.c17cd62d-ff5d-47ba-8673-3346c7f2365f2026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062286
application number: ANDA062286
ndc (product): 43063-180
Dicloxacillin SodiumDICLOXACILLIN SODIUMPD-Rx Pharmaceuticals, Inc.9e2bbe03-44cb-45d1-acdb-b61d9016055e2025-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062286
application number: ANDA062286
ndc (product): 55289-592
Dicloxacillin SodiumDICLOXACILLIN SODIUMPD-Rx Pharmaceuticals, Inc.24e821aa-85b8-4f5a-aa13-83ff132952ca2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062286
application number: ANDA062286
ndc (product): 43063-473
Dicloxacillin SodiumDICLOXACILLIN SODIUMBryant Ranch Prepack3e4842ec-773b-4aeb-b37d-1c4e3cf534242024-01-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062286
application number: ANDA062286
ndc (product): 63629-4256
Dicloxacillin SodiumDICLOXACILLIN SODIUMTeva Pharmaceuticals USA, Inc.8478f242-c715-4984-ac1d-dc79dc28665e2022-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062286
application number: ANDA062286
ndc (product): 0093-3125
ndc (product): 0093-3123
Dicloxacillin SodiumDICLOXACILLIN SODIUMAsclemed USA, Inc.a4174fda-68f7-4834-be58-dd6b167cf9f02020-11-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062286
application number: ANDA062286
ndc (product): 76420-183

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3123Dicloxacillin SodiumDicloxacillin SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3123Dicloxacillin SodiumDicloxacillin SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3123Dicloxacillin SodiumDicloxacillin SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3123Dicloxacillin SodiumDicloxacillin SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3123Dicloxacillin SodiumDicloxacillin SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3125Dicloxacillin SodiumDicloxacillin SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3125Dicloxacillin SodiumDicloxacillin SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3125Dicloxacillin SodiumDicloxacillin SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3125Dicloxacillin SodiumDicloxacillin SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3125Dicloxacillin SodiumDicloxacillin SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0440-7380Dicloxacillin SodiumDicloxacillin SodiumLiberty Pharmaceuticals, Inc.ANDACurrent
33261-167Dicloxacillin SodiumDicloxacillin SodiumAidarex Pharmaceuticals LLCANDACurrent
42291-216Dicloxacillin SodiumDicloxacillin SodiumAvKARE, Inc.ANDACurrent
43063-180Dicloxacillin SodiumDicloxacillin SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-180Dicloxacillin SodiumDicloxacillin SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-180Dicloxacillin SodiumDicloxacillin SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-180Dicloxacillin SodiumDicloxacillin SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-473Dicloxacillin SodiumDicloxacillin SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-473Dicloxacillin SodiumDicloxacillin SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-473Dicloxacillin SodiumDicloxacillin SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-473Dicloxacillin SodiumDicloxacillin SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0116Dicloxacillin SodiumDicloxacillin SodiumA-S Medication SolutionsANDACurrent
50090-0116Dicloxacillin SodiumDicloxacillin SodiumA-S Medication SolutionsANDACurrent
50090-0116Dicloxacillin SodiumDicloxacillin SodiumA-S Medication SolutionsANDACurrent
50090-0116Dicloxacillin SodiumDicloxacillin SodiumA-S Medication SolutionsANDACurrent
50090-0310Dicloxacillin SodiumDicloxacillin SodiumA-S Medication SolutionsANDACurrent
50090-0310Dicloxacillin SodiumDicloxacillin SodiumA-S Medication SolutionsANDACurrent
50090-0310Dicloxacillin SodiumDicloxacillin SodiumA-S Medication SolutionsANDACurrent
50090-0310Dicloxacillin SodiumDicloxacillin SodiumA-S Medication SolutionsANDACurrent
50090-0310Dicloxacillin SodiumDicloxacillin SodiumA-S Medication SolutionsANDACurrent
50090-0310Dicloxacillin SodiumDicloxacillin SodiumA-S Medication SolutionsANDACurrent
50090-2276Dicloxacillin SodiumDicloxacillin SodiumA-S Medication SolutionsANDACurrent
52959-049Dicloxacillin SodiumDicloxacillin SodiumH.J. Harkins Company, Inc.ANDACurrent
55289-592Dicloxacillin SodiumDicloxacillin SodiumPD-Rx Pharmaceuticals, InANDACurrent
55289-592Dicloxacillin SodiumDicloxacillin SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-592Dicloxacillin SodiumDicloxacillin SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-592Dicloxacillin SodiumDicloxacillin SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-592Dicloxacillin SodiumDicloxacillin SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-592Dicloxacillin SodiumDicloxacillin SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
63629-4256Dicloxacillin SodiumDicloxacillin SodiumBryant Ranch PrepackANDACurrent
63629-4256Dicloxacillin SodiumDicloxacillin SodiumBryant Ranch PrepackANDACurrent
66267-073Dicloxacillin SodiumDicloxacillin SodiumNuCare Pharmaceticals, Inc.ANDACurrent
66267-073Dicloxacillin SodiumDicloxacillin SodiumNuCare Pharmaceticals, Inc.ANDACurrent
66267-073Dicloxacillin SodiumDicloxacillin SodiumNuCare Pharmaceticals, Inc.ANDACurrent
66267-073Dicloxacillin SodiumDicloxacillin SodiumNuCare Pharmaceticals, Inc.ANDACurrent
67296-0122Dicloxacillin SodiumDicloxacillin SodiumRedPharm Drug Inc.ANDACurrent
76420-183Dicloxacillin SodiumDicloxacillin SodiumAsclemed USA, Inc.ANDACurrent