Sulfameth/Trimeth-DS

Product NDC: 61919-645
Requested package NDC: 61919-645-20
11-digit product format: 619190645
Labeler code: 61919
Product ID: 61919-645_47e154aa-d636-469b-e063-6394a90ad9b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfameth/Trimeth-DS
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA090624
Marketing category: ANDA
Marketing start: 2019-08-13
Substance: SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength: 800; 160 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: 2027-12-31
Current FDA listing: Yes

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	61919-645	61919-645-20	I	Inactivated by FDA		2026-10-05

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 · 9 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	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB		2010-02-16
A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB		2010-02-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090624-001	AB
A090624-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090624-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2010-02-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090624-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2010-02-16	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090624-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090624-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090624-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090624-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090624-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090624-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090624-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090624-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090624-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090624-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090624-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090624-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090624-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090624-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090624-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090624-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090624-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090624-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090624-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090624-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090624-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090624-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090624-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090624-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090624-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090624-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090624-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090624-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090624-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090624-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090624-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090624-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090624-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090624-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090624-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090624-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090624-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090624-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090624-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090624-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Sulfameth/Trimeth-DS
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SULFAMETHOXAZOLE	800 mg/1
TRIMETHOPRIM	160 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JE42381TNV	Internal UNII lookup
AN164J8Y0X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198335	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
90026ce8-3305-6272-e053-2995a90a57e0	Available on FDA.report

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, Indexing SPL, Related label table
NDC	Indexing SPL	Related label
61919-645-02	2cef2736-9504-d83d-e063-dadaa90ab31f	Sulfameth/Trimeth-DS
61919-645-10	2cef2736-7750-d83d-e063-dadaa90ab31f	Sulfameth/Trimeth-DS
61919-645-14	2cef2736-68fc-d83d-e063-dadaa90ab31f	Sulfameth/Trimeth-DS
61919-645-20	2cef2736-7e6f-d83d-e063-dadaa90ab31f	SULFAMETH/TRIMETH DS
61919-645-28	2cef2736-8f50-d83d-e063-dadaa90ab31f	SULFAMETH/TRIMETH-DS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-645-06	Sulfameth/Trimeth-DS	6 in 1 BOTTLE	TABLET	6	7
61919-645-30	Sulfameth/Trimeth-DS	30 in 1 BOTTLE	TABLET	30	7
61919-645-56	Sulfameth/Trimeth-DS	56 in 1 BOTTLE	TABLET	56	7
61919-645-60	Sulfameth/Trimeth-DS	60 in 1 BOTTLE	TABLET	60	7
61919-645-02	Sulfameth/Trimeth-DS	2 in 1 BOTTLE	TABLET	2	1
61919-645-10	Sulfameth/Trimeth-DS	10 in 1 BOTTLE	TABLET	10	1
61919-645-14	Sulfameth/Trimeth-DS	14 in 1 BOTTLE	TABLET	14	1
61919-645-20	SULFAMETH/TRIMETH-DS	20 in 1 BOTTLE	TABLET	20	1
61919-645-28	SULFAMETH/TRIMETH-DS	28 in 1 BOTTLE	TABLET	28	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-645-02	EA - Each	61919-645	bf3b9bdf-91fe-4aa7-9488-deb0c54dd1a5	1	2019-08-06
61919-645-10	EA - Each	61919-645	1d27bf1a-3602-44eb-977a-6e39d8694729	1	2019-08-06
61919-645-14	EA - Each	61919-645	e97cad26-5750-460b-9180-62e2584d90d6	1	2019-09-05
61919-645-20	EA - Each	61919-645	b0b61e65-fc68-48e5-96e2-b2f8f783df9d	1	2019-05-02
61919-645-28	EA - Each	61919-645	16c2b04e-8277-4abe-afe0-6dfe33dc7439	1	2019-09-05
61919-645-56	EA - Each	61919-645	91673680-56ce-4ba6-a230-6f99b656ca91	1	2022-06-06
61919-645-60	EA - Each	61919-645	cf6adc0f-6cc9-4ac1-b6ef-6d3ba78f5638	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-645	SULFAMETH/TRIMETH-DS TABLET [DIRECT_RX]	6	Current NDC, Legacy NDC, 4 package rows	20240402_90026ce8-3305-6272-e053-2995a90a57e0.zip
61919-645	SULFAMETH/TRIMETH-DS TABLET [DIRECT RX]	1	Current NDC, Legacy NDC, 1 package rows	20190117_7cc4029e-5f4b-880a-e053-2991aa0a3264.zip
61919-645	SULFAMETH/TRIMETH-DS TABLET [DIRECT_RX]	1	Current NDC, Legacy NDC, 1 package rows	20190703_8cb4ed51-aa27-f6e6-e053-2a95a90a7df5.zip
61919-645	SULFAMETH/TRIMETH-DS TABLET [DIRECT_RX]	1	Current NDC, Legacy NDC, 1 package rows	20190720_8de58d77-c631-2b9d-e053-2995a90a54ea.zip
61919-645	SULFAMETH/TRIMETH-DS TABLET [DIRECT_RX]	1	Current NDC, Legacy NDC, 1 package rows	20190806_8f72fca6-7dba-641f-e053-2a95a90ad148.zip
61919-645	SULFAMETH/TRIMETH-DS TABLET [DIRECTRX]	1	Current NDC, Legacy NDC, 1 package rows	20190423_87240462-3840-5045-e053-2991aa0a4341.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 3 · 47 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Preferred Pharmaceuticals Inc.	d60c218c-6529-4944-af0b-a9dc720f32e9	2026-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	REMEDYREPACK INC.	ce44959b-4bfe-4ba9-9fc2-7f9d4663d542	2026-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	REMEDYREPACK INC.	ec2e335c-3357-40d8-9615-a09fc40ce5f4	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	REMEDYREPACK INC.	c45ac3a4-d397-486e-abd1-349916543068	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Cardinal Health 107, LLC	08500fcb-dbec-4ac2-91c3-189d27907ec0	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Unit Dose Solutions, Inc.	562e2547-db2d-e2d2-e063-6294a90a1f5d	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	St. Mary's Medical Park Pharmacy	e3a49508-0ebe-1334-e053-2a95a90ae173	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Coupler LLC	518cc045-a12b-f08f-e063-6394a90acb0c	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	AvPAK	29df8839-3dfa-0b2b-c5a3-906db6997b3b	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	75b9d194-b960-4943-bedc-96e3d65c4da9	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	NuCare Pharmaceuticals,Inc.	7f82e5e0-b627-a3f3-e053-2991aa0abaa5	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Sportpharm LLC	52304e5e-d097-48f2-8b64-210908e4eb54	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	REMEDYREPACK INC.	99e1ace6-7665-4f87-82fd-5e7c4989e098	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfameth/Trimeth-DS	SULFAMETH/TRIMETH-DS	Direct_Rx	90026ce8-3305-6272-e053-2995a90a57e0	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624 ndc (product): 61919-645
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	NuCare Pharmaceuticals,Inc.	8c3e4738-0e0a-a854-e053-2995a90a7d71	2026-01-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Northwind Health Company, LLC	f7f97520-d063-ec87-e053-6294a90aae0c	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Northwind Health Company, LLC	471c5995-a4df-fbe3-e063-6394a90aa50e	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	QPharma, Inc.	41529314-b203-47f4-88dd-5aa57c74985f	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	VERITYRX, LLC	427b8040-99a4-8e81-e063-6394a90a76c5	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	NuCare Pharmaceuticals,Inc.	1274cefb-0799-e2e4-e063-6394a90aad02	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090624 application number: ANDA090624

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	90026ce8-3305-6272-e053-2995a90a57e0	7
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	90026ce8-3305-6272-e053-2995a90a57e0	7
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	90026ce8-3305-6272-e053-2995a90a57e0	7
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	7cc4029e-5f4b-880a-e053-2991aa0a3264	1
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	87240462-3840-5045-e053-2991aa0a4341	1
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	8f72fca6-7dba-641f-e053-2a95a90ad148	1
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	8cb4ed51-aa27-f6e6-e053-2a95a90a7df5	1
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	PSN	8de58d77-c631-2b9d-e053-2995a90a54ea	1
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	7cc4029e-5f4b-880a-e053-2991aa0a3264	1
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	8f72fca6-7dba-641f-e053-2a95a90ad148	1
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	8de58d77-c631-2b9d-e053-2995a90a54ea	1
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	8cb4ed51-aa27-f6e6-e053-2a95a90a7df5	1
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	87240462-3840-5045-e053-2991aa0a4341	1
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	8de58d77-c631-2b9d-e053-2995a90a54ea	1
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	8f72fca6-7dba-641f-e053-2a95a90ad148	1
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	8cb4ed51-aa27-f6e6-e053-2a95a90a7df5	1
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	87240462-3840-5045-e053-2991aa0a4341	1
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	7cc4029e-5f4b-880a-e053-2991aa0a3264	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-645-20	61919064520	20 TABLET in 1 BOTTLE (61919-645-20)	20 tablet	2019-04-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulfameth/Trimeth-DS	Direct_Rx	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	7
Sulfameth/Trimeth-DS	Direct_Rx \| 079254320	2019-08-06	HUMAN PRESCRIPTION DRUG LABEL	1
Sulfameth/Trimeth-DS	Direct_Rx	2019-07-17	HUMAN PRESCRIPTION DRUG LABEL	1
Sulfameth/Trimeth-DS	Direct_Rx	2019-07-02	HUMAN PRESCRIPTION DRUG LABEL	1
SULFAMETH/TRIMETH DS	DirectRX	2019-04-22	HUMAN PRESCRIPTION DRUG LABEL	1
SULFAMETH/TRIMETH-DS	DIRECT RX	2018-12-11	HUMAN PRESCRIPTION DRUG LABEL	1