Dicloxacillin Sodium

Product NDC: 67296-1205
11-digit product format: 672961205
Labeler code: 67296
Product ID: 67296-1205_d610062d-3998-dec3-e053-2995a90a9ca1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dicloxacillin Sodium
Dosage form: CAPSULE
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA061454
Marketing category: ANDA
Marketing start: 1971-04-01
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	67296-1205		I	Inactivated by FDA		2026-08-03
excluded package	package	67296-1205	67296-1205-4	I	Inactivated by FDA		2026-08-03

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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67296-1205-4	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67296-1205-4	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67296-1205-4	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67296-1205-4	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67296-1205-4	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67296-1205-4	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67296-1205-4	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67296-1205-4	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67296-1205-4	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67296-1205-4	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67296-1205-4	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67296-1205-4	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67296-1205-4	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67296-1205-4	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67296-1205-4	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	67296-1205-4	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67296-1205-4	2024-01-30	C162847	48780-1	1030e365-44b4-111a-e063-dadaa90a10e2	4f0941aa-8496-10d1-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67296-1205-4	Dicloxacillin Sodium	40 in 1 BOTTLE	CAPSULE	40		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-1205	DICLOXACILLIN SODIUM CAPSULE [REDPHARM DRUG, INC.]	3	Legacy NDC, 1 package rows	20220121_4f0941aa-8496-10d1-e054-00144ff8d46c.zip

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	4f0941aa-8496-10d1-e054-00144ff8d46c	3
197596	dicloxacillin 500 MG Oral Capsule	SCD	4f0941aa-8496-10d1-e054-00144ff8d46c	3
197596	dicloxacillin (as dicloxacillin sodium) 500 MG Oral Capsule	SY	4f0941aa-8496-10d1-e054-00144ff8d46c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-1205-4	67296120504	40 CAPSULE in 1 BOTTLE (67296-1205-4)	40 capsule	1971-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dicloxacillin Sodium - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2022-01-20	HUMAN PRESCRIPTION DRUG LABEL	3