Dicloxacillin Sodium

Product NDC
50090-0116
11-digit product format
500900116
Labeler code
50090
Product ID
50090-0116_d57fa00e-29a4-4e5c-bae1-0eb8ad4111f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicloxacillin Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-0116DDiscontinued by firm2026-08-03
excluded packagepackage50090-011650090-0116-0DDiscontinued by firm2026-08-03
excluded packagepackage50090-011650090-0116-1DDiscontinued by firm2026-08-03
excluded packagepackage50090-011650090-0116-4DDiscontinued by firm2026-08-03

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…

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
50090-0116-0Dicloxacillin Sodium28 in 1 BOTTLECAPSULE2826
50090-0116-1Dicloxacillin Sodium40 in 1 BOTTLECAPSULE4026
50090-0116-4Dicloxacillin Sodium20 in 1 BOTTLECAPSULE2026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0116-1EA - Each50090-0116e9f03198-c92a-401f-ab79-72dfee55d2f412018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOXACILLIN SODIUMACTIVE INGREDIENT4HZT2V9KX0DICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
DICLOXACILLINACTIVE MOIETYCOF19H7WBKDICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LDICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SHELLACINACTIVE INGREDIENT46N107B71ODICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SORBITAN MONOLAURATEINACTIVE INGREDIENT6W9PS8B71JDICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0116DICLOXACILLIN SODIUM CAPSULE [A-S MEDICATION SOLUTIONS]26Current NDC, Legacy NDC, 3 package rows20241023_69a08b51-3175-4100-8ca2-5a061d909367.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0116-05009001160028 CAPSULE in 1 BOTTLE (50090-0116-0) 28 capsule2013-12-180000-00-00NoNoCurrent
50090-0116-15009001160140 CAPSULE in 1 BOTTLE (50090-0116-1) 40 capsule2014-11-280000-00-00NoNoCurrent
50090-0116-45009001160420 CAPSULE in 1 BOTTLE (50090-0116-4) 20 capsule2013-11-130000-00-00NoNoCurrent