Sulfamethoxazole and Trimethoprim

Product NDC: 67296-0387
Requested package NDC: 67296-0387-4
11-digit product format: 672960387
Labeler code: 67296
Product ID: 67296-0387_d5fc2560-df27-e0f6-e053-2a95a90a5ef8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfamethoxazole and Trimethoprim
Dosage form: TABLET
Route: ORAL
Labeler: RedPharm Drug, Inc.
Application: ANDA071017
Marketing category: ANDA
Marketing start: 1986-08-25
Marketing end: 0000-00-00
Substance: SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength: 800 mg/1; mg/1
Pharmacologic classes: Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67296-0387	67296-0387-4	D	Discontinued by firm		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 · 12 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2019-12-08 06:16 UTC · source 2019-12-05	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB		1986-08-25
A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB		1986-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071017-001	AB
A071017-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071017-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	1986-08-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A071017-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	1986-08-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A071017-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071017-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071017-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071017-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071017-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071017-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071017-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071017-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071017-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071017-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071017-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071017-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071017-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071017-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071017-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071017-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071017-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071017-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071017-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071017-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071017-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071017-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071017-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071017-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071017-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071017-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071017-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071017-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071017-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071017-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071017-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071017-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071017-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071017-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071017-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071017-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071017-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071017-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071017-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A071017-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4ce811b5-329e-27f8-b5ff-66d52b435c00	Product name	3	20240108
8d30c4f0-0228-cea4-e3aa-f19064c47f27	Product name	3	20221128
6e20c430-5e8f-85da-1b03-f7dbc0c51fad	Product name	3	20190926
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
67296-0387-1	4196e73b-5aec-2ede-e054-00144ff8d46c
67296-0387-2	4196e73b-5aec-2ede-e054-00144ff8d46c
67296-0387-3	4196e73b-5aec-2ede-e054-00144ff8d46c
67296-0387-4	4196e73b-5aec-2ede-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67296-0387-1	Sulfamethoxazole and Trimethoprim	10 in 1 BOTTLE	TABLET	10	5
67296-0387-2	Sulfamethoxazole and Trimethoprim	6 in 1 BOTTLE	TABLET	6	5
67296-0387-3	Sulfamethoxazole and Trimethoprim	20 in 1 BOTTLE	TABLET	20	5
67296-0387-4	Sulfamethoxazole and Trimethoprim	14 in 1 BOTTLE	TABLET	14	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67296-0387	SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [REDPHARM DRUG, INC.]	5	Legacy NDC, 4 package rows	20240711_4196e73b-5aec-2ede-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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Golden State Medical Supply, Inc.	bd3161fe-23d7-458a-86a4-fb958d9c94d3	2025-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071017 application number: ANDA071017
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Sun Pharmaceutical Industries, Inc.	4833319a-a7b3-4bf4-bec4-6531b43182d4	2025-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071017 application number: ANDA071017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JE42381TNV	SULFAMETHOXAZOLE	723-46-6	SULFAMETHOXAZOLE
AN164J8Y0X	TRIMETHOPRIM	738-70-5	TRIMETHOPRIM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	4196e73b-5aec-2ede-e054-00144ff8d46c	5
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	4196e73b-5aec-2ede-e054-00144ff8d46c	5
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	4196e73b-5aec-2ede-e054-00144ff8d46c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67296-0387-4	67296038704	14 TABLET in 1 BOTTLE (67296-0387-4)	14 tablet	1986-08-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulfamethoxazole and Trimethoprim - RedPharm Drug, Inc.	RedPharm Drug, Inc.	2024-07-10	HUMAN PRESCRIPTION DRUG LABEL	5