Dicloxacillin Sodium

Product NDC
55289-592
11-digit product format
552890592
Labeler code
55289
Product ID
55289-592_419b12d0-b5a9-5656-e063-6394a90a2d15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicloxacillin Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA062286
Marketing category
ANDA
Marketing start
1990-09-30
Substance
DICLOXACILLIN SODIUM
Active strength
250 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Dicloxacillin Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOXACILLIN SODIUM250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4HZT2V9KX0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197595Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9e2bbe03-44cb-45d1-acdb-b61d9016055eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce7f6212-eff4-e8f0-b733-f4aa5877dfa0Product name220231211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55289-592-10Dicloxacillin Sodium10 in 1 BOTTLE, PLASTICCAPSULE1016
55289-592-20Dicloxacillin Sodium20 in 1 BOTTLE, PLASTICCAPSULE2016
55289-592-28Dicloxacillin Sodium28 in 1 BOTTLE, PLASTICCAPSULE2816
55289-592-40Dicloxacillin Sodium40 in 1 BOTTLE, PLASTICCAPSULE4016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-592-10EA - Each55289-59218d9dc9a-8e5e-48e3-8c75-95604d451afe12012-07-24
55289-592-20EA - Each55289-5924a26060e-6390-406f-839b-7ae7e8d1c75812012-07-24
55289-592-28EA - Each55289-592fad28969-e8c3-412c-a4c0-e2217e467af612012-07-24
55289-592-40EA - Each55289-592a31dffd7-9dbf-4494-b485-ed40b11a49a112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOXACILLIN SODIUMACTIVE INGREDIENT4HZT2V9KX0DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
DICLOXACILLINACTIVE MOIETYCOF19H7WBKDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-592DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 4 package rows20241012_9e2bbe03-44cb-45d1-acdb-b61d9016055e.zip

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
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
Dicloxacillin SodiumDICLOXACILLIN SODIUMBryant Ranch Prepack3e4842ec-773b-4aeb-b37d-1c4e3cf534242024-01-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062286
application number: ANDA062286
Dicloxacillin SodiumDICLOXACILLIN SODIUMTeva Pharmaceuticals USA, Inc.8478f242-c715-4984-ac1d-dc79dc28665e2022-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062286
application number: ANDA062286
Dicloxacillin SodiumDICLOXACILLIN SODIUMAsclemed USA, Inc.a4174fda-68f7-4834-be58-dd6b167cf9f02020-11-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062286
application number: ANDA062286

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197595dicloxacillin sodium 250 MG Oral CapsulePSN9e2bbe03-44cb-45d1-acdb-b61d9016055e16
197595dicloxacillin 250 MG Oral CapsuleSCD9e2bbe03-44cb-45d1-acdb-b61d9016055e16
197595dicloxacillin (as dicloxacillin sodium) 250 MG Oral CapsuleSY9e2bbe03-44cb-45d1-acdb-b61d9016055e16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-592-105528905921010 CAPSULE in 1 BOTTLE, PLASTIC (55289-592-10) 10 capsule2011-01-200000-00-00NoNoCurrent
55289-592-205528905922020 CAPSULE in 1 BOTTLE, PLASTIC (55289-592-20) 20 capsule2011-01-200000-00-00NoNoCurrent
55289-592-285528905922828 CAPSULE in 1 BOTTLE, PLASTIC (55289-592-28) 28 capsule2011-01-200000-00-00NoNoCurrent
55289-592-405528905924040 CAPSULE in 1 BOTTLE, PLASTIC (55289-592-40) 40 capsule2011-01-200000-00-00NoNoCurrent