Dicloxacillin Sodium

Product NDC
66267-073
11-digit product format
662670073
Labeler code
66267
Product ID
66267-073_d57979c0-6d4b-5e32-e053-2995a90ab8ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicloxacillin Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceticals, Inc.
Application
ANDA062286
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
DICLOXACILLIN SODIUM
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66267-073IInactivated by FDA2026-08-03
excluded packagepackage66267-07366267-073-28IInactivated by FDA2026-08-03
excluded packagepackage66267-07366267-073-30IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 27 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66267-073-30IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66267-073-28IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66267-073-30IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66267-073-28IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66267-073-30IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66267-073-28IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66267-073-30IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66267-073-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66267-073-30IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66267-073-28IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66267-073-30IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66267-073-28IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66267-073-28UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66267-073-30UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66267-073-28UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66267-073-30UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66267-073-28UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66267-073-30UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-073-28Dicloxacillin Sodium28 in 1 BOTTLECAPSULE284
66267-073-30Dicloxacillin Sodium30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-073-28EA - Each66267-0737f48c1f4-3134-4429-9d4a-f2cff2f96b1f12016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-073DICLOXACILLIN SODIUM CAPSULE [NUCARE PHARMACETICALS, INC.]4Legacy NDC, 2 package rows20220114_3dbcccb5-5a36-45cf-e054-00144ff8d46c.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197596dicloxacillin sodium 500 MG Oral CapsulePSN3dbcccb5-5a36-45cf-e054-00144ff8d46c4
197596dicloxacillin 500 MG Oral CapsuleSCD3dbcccb5-5a36-45cf-e054-00144ff8d46c4
197596dicloxacillin (as dicloxacillin sodium) 500 MG Oral CapsuleSY3dbcccb5-5a36-45cf-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-073-286626700732828 CAPSULE in 1 BOTTLE (66267-073-28) 28 capsule2016-09-300000-00-00NoNoCurrent
66267-073-306626700733030 CAPSULE in 1 BOTTLE (66267-073-30) 30 capsule2016-09-300000-00-00NoNoCurrent