Dicloxacillin Sodium

Product NDC: 76420-183
11-digit product format: 764200183
Labeler code: 76420
Product ID: 76420-183_b41444ca-246e-b54e-e053-2a95a90ae0e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicloxacillin Sodium
Dosage form: CAPSULE
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA062286
Marketing category: ANDA
Marketing start: 1990-09-30
Substance: DICLOXACILLIN SODIUM
Active strength: 500 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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A062286-001	DICLOXACILLIN SODIUM	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03
A062286-002	DICLOXACILLIN SODIUM	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1982-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL			1982-06-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL		RS	1982-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL			1982-06-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL		RS	1982-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL			1982-06-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL		RS	1982-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	AB		1982-06-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	AB		1982-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL			1982-06-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL		RS	1982-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062286-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL			1982-06-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A062286-002	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL		RS	1982-06-03	`782e0a99824c…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A062286-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062286-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062286-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062286-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062286-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062286-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062286-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062286-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062286-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062286-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062286-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062286-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062286-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062286-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062286-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062286-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062286-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062286-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062286-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062286-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062286-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062286-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062286-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062286-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062286-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062286-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062286-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062286-002	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A062286-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062286-002	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A062286-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A062286-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062286-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A062286-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062286-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A062286-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062286-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A062286-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062286-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A062286-002	AB	1	`ea99ee380514…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOXACILLIN SODIUM	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4HZT2V9KX0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197596	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
a4174fda-68f7-4834-be58-dd6b167cf9f0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ce7f6212-eff4-e8f0-b733-f4aa5877dfa0	Product name	2	20231211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76420-183-20	Dicloxacillin Sodium	20 in 1 BOTTLE	CAPSULE	20		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-183	DICLOXACILLIN SODIUM CAPSULE [ASCLEMED USA, INC.]	1	Current NDC, Legacy NDC, 1 package rows	20201117_a4174fda-68f7-4834-be58-dd6b167cf9f0.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DICLOXACILLIN SODIUM	DICLOXACILLIN SODIUM	Chartwell RX, LLC	270c0839-c30c-475d-a505-e70855652c9e	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062286 application number: ANDA062286
Dicloxacillin Sodium	DICLOXACILLIN SODIUM	PD-Rx Pharmaceuticals, Inc.	c17cd62d-ff5d-47ba-8673-3346c7f2365f	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062286 application number: ANDA062286
Dicloxacillin Sodium	DICLOXACILLIN SODIUM	PD-Rx Pharmaceuticals, Inc.	9e2bbe03-44cb-45d1-acdb-b61d9016055e	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062286 application number: ANDA062286
Dicloxacillin Sodium	DICLOXACILLIN SODIUM	PD-Rx Pharmaceuticals, Inc.	24e821aa-85b8-4f5a-aa13-83ff132952ca	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062286 application number: ANDA062286
Dicloxacillin Sodium	DICLOXACILLIN SODIUM	Bryant Ranch Prepack	3e4842ec-773b-4aeb-b37d-1c4e3cf53424	2024-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062286 application number: ANDA062286
Dicloxacillin Sodium	DICLOXACILLIN SODIUM	Teva Pharmaceuticals USA, Inc.	8478f242-c715-4984-ac1d-dc79dc28665e	2022-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062286 application number: ANDA062286
Dicloxacillin Sodium	DICLOXACILLIN SODIUM	Asclemed USA, Inc.	a4174fda-68f7-4834-be58-dd6b167cf9f0	2020-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062286 application number: ANDA062286 ndc (product): 76420-183

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4HZT2V9KX0	DICLOXACILLIN SODIUM	13412-64-1	DICLOXACILLIN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197596	dicloxacillin sodium 500 MG Oral Capsule	PSN	a4174fda-68f7-4834-be58-dd6b167cf9f0	1
197596	dicloxacillin 500 MG Oral Capsule	SCD	a4174fda-68f7-4834-be58-dd6b167cf9f0	1
197596	dicloxacillin (as dicloxacillin sodium) 500 MG Oral Capsule	SY	a4174fda-68f7-4834-be58-dd6b167cf9f0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76420-183-20	76420018320	20 CAPSULE in 1 BOTTLE (76420-183-20)	20 capsule	2020-11-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dicloxacillin Sodium Capsules USP Rx only	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2020-11-14	HUMAN PRESCRIPTION DRUG LABEL	1