Application 061454

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DICLOXACILLIN SODIUM	DICLOXACILLIN SODIUM	CAPSULE;ORAL	EQ 250MG BASE	No	No
002	DICLOXACILLIN SODIUM	DICLOXACILLIN SODIUM	CAPSULE;ORAL	EQ 125MG BASE	No	No
003	DICLOXACILLIN SODIUM	DICLOXACILLIN SODIUM	CAPSULE;ORAL	EQ 500MG BASE	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
A061454-001	DICLOXACILLIN SODIUM	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982
A061454-002	DICLOXACILLIN SODIUM	DICLOXACILLIN SODIUM	EQ 125MG BASE	CAPSULE / ORAL	Approved before 1982
A061454-003	DICLOXACILLIN SODIUM	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A061454-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061454-002	DICLOXACILLIN SODIUM	EQ 125MG BASE	CAPSULE / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061454-003	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061454-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061454-002	DICLOXACILLIN SODIUM	EQ 125MG BASE	CAPSULE / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061454-003	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061454-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061454-002	DICLOXACILLIN SODIUM	EQ 125MG BASE	CAPSULE / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061454-003	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061454-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061454-002	DICLOXACILLIN SODIUM	EQ 125MG BASE	CAPSULE / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061454-003	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061454-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061454-002	DICLOXACILLIN SODIUM	EQ 125MG BASE	CAPSULE / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061454-003	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061454-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061454-002	DICLOXACILLIN SODIUM	EQ 125MG BASE	CAPSULE / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061454-003	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061454-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061454-002	DICLOXACILLIN SODIUM	EQ 125MG BASE	CAPSULE / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061454-003	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061454-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061454-002	DICLOXACILLIN SODIUM	EQ 125MG BASE	CAPSULE / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061454-003	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061454-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061454-002	DICLOXACILLIN SODIUM	EQ 125MG BASE	CAPSULE / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061454-003	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061454-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061454-002	DICLOXACILLIN SODIUM	EQ 125MG BASE	CAPSULE / ORAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061454-003	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061454-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061454-002	DICLOXACILLIN SODIUM	EQ 125MG BASE	CAPSULE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061454-003	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061454-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061454-002	DICLOXACILLIN SODIUM	EQ 125MG BASE	CAPSULE / ORAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061454-003	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061454-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061454-002	DICLOXACILLIN SODIUM	EQ 125MG BASE	CAPSULE / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061454-003	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A061454-001	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE / ORAL	Approved before 1982	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A061454-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A061454-003	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A061454-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A061454-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A061454-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A061454-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A061454-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A061454-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A061454-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A061454-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A061454-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A061454-003	AB	1	`ea99ee380514…`

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 · 8 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	Name fallback brand name: DICLOXACILLIN SODIUM generic name: DICLOXACILLIN SODIUM
Dicloxacillin Sodium	DICLOXACILLIN SODIUM	PD-Rx Pharmaceuticals, Inc.	c17cd62d-ff5d-47ba-8673-3346c7f2365f	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Dicloxacillin Sodium generic name: DICLOXACILLIN SODIUM
Dicloxacillin Sodium	DICLOXACILLIN SODIUM	PD-Rx Pharmaceuticals, Inc.	9e2bbe03-44cb-45d1-acdb-b61d9016055e	2025-10-20	Warnings, Adverse reactions	Name fallback brand name: Dicloxacillin Sodium generic name: DICLOXACILLIN SODIUM
Dicloxacillin Sodium	DICLOXACILLIN SODIUM	PD-Rx Pharmaceuticals, Inc.	24e821aa-85b8-4f5a-aa13-83ff132952ca	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Dicloxacillin Sodium generic name: DICLOXACILLIN SODIUM
Dicloxacillin Sodium	DICLOXACILLIN SODIUM	Bryant Ranch Prepack	3e4842ec-773b-4aeb-b37d-1c4e3cf53424	2024-01-18	Warnings, Adverse reactions	Name fallback brand name: Dicloxacillin Sodium generic name: DICLOXACILLIN SODIUM
DICLOXACILLIN SODIUM	DICLOXACILLIN SODIUM	Aurobindo Pharma Limited	9074b5a6-850c-4144-9097-bb21073ee54d	2023-12-27	Warnings, Adverse reactions	Name fallback brand name: DICLOXACILLIN SODIUM generic name: DICLOXACILLIN SODIUM
Dicloxacillin Sodium	DICLOXACILLIN SODIUM	Teva Pharmaceuticals USA, Inc.	8478f242-c715-4984-ac1d-dc79dc28665e	2022-06-22	Warnings, Adverse reactions	Name fallback brand name: Dicloxacillin Sodium generic name: DICLOXACILLIN SODIUM
Dicloxacillin Sodium	DICLOXACILLIN SODIUM	Asclemed USA, Inc.	a4174fda-68f7-4834-be58-dd6b167cf9f0	2020-11-14	Warnings, Adverse reactions	Name fallback brand name: Dicloxacillin Sodium generic name: DICLOXACILLIN SODIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0440-1380	Dicloxacillin Sodium	Dicloxacillin Sodium	Liberty Pharmaceuticals, Inc.	ANDA	Current
0781-2248	Dicloxacillin Sodium	Dicloxacillin Sodium	Sandoz Inc	ANDA	Current
0781-2248	Dicloxacillin Sodium	Dicloxacillin Sodium	Sandoz Inc	ANDA	Current
0781-2258	Dicloxacillin Sodium	Dicloxacillin Sodium	Sandoz Inc	ANDA	Current
0781-2258	Dicloxacillin Sodium	Dicloxacillin Sodium	Sandoz Inc	ANDA	Current
21695-124	Dicloxacillin Sodium	Dicloxacillin Sodium	Rebel Distributors Corp	ANDA	Current
50090-1702	Dicloxacillin Sodium	Dicloxacillin Sodium	A-S Medication Solutions	ANDA	Current
55289-094	Dicloxacillin Sodium	Dicloxacillin Sodium	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
63629-1350	Dicloxacillin Sodium	Dicloxacillin Sodium	Bryant Ranch Prepack	ANDA	Current
67296-1205	Dicloxacillin Sodium	Dicloxacillin Sodium	RedPharm Drug, Inc.	ANDA	Current
67296-1205	Dicloxacillin Sodium	Dicloxacillin Sodium	RedPharm Drug, Inc.	ANDA	Current
67296-1205	Dicloxacillin Sodium	Dicloxacillin Sodium	RedPharm Drug, Inc.	ANDA	Current