Sulfamethox-TMP DS

Product NDC: 54348-625
Requested package NDC: 54348-625-06
11-digit product format: 543480625
Labeler code: 54348
Product ID: 54348-625_ea935f93-6c2d-2e8a-e053-2995a90a2ce0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SULFAMETHOXAZOLE, TRIMETHOPRIM
Dosage form: TABLET
Route: ORAL
Labeler: PharmPak, Inc.
Application: ANDA076899
Marketing category: ANDA
Marketing start: 2019-07-11
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: 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
A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB		2005-01-27
A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB		2005-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076899-001	AB
A076899-002	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	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076899-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	400MG;80MG	TABLET / ORAL	AB	2005-01-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076899-002	SULFAMETHOXAZOLE AND TRIMETHOPRIM	800MG;160MG	TABLET / ORAL	AB	2005-01-27	`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	A076899-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076899-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076899-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076899-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076899-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076899-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076899-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076899-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076899-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076899-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076899-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076899-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076899-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076899-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076899-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076899-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076899-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076899-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076899-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076899-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076899-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076899-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076899-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076899-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076899-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076899-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076899-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076899-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076899-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076899-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076899-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076899-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076899-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076899-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076899-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076899-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076899-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076899-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076899-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076899-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sulfamethox-TMP DS
Listing expiration: 2026-12-31

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
ede74118-32c5-4f52-9823-509538e674c8	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54348-625-06	Sulfamethox-TMP DS	1 in 1 BOX	TABLET	1	2
54348-625-06	Sulfamethox-TMP DS	6 in 1 BOTTLE	TABLET	6	2
54348-625-10	Sulfamethox-TMP DS	10 in 1 BOTTLE	TABLET	10	2
54348-625-10	Sulfamethox-TMP DS	1 in 1 BOX	TABLET	1	2
54348-625-14	Sulfamethox-TMP DS	14 in 1 BOTTLE	TABLET	14	2
54348-625-14	Sulfamethox-TMP DS	1 in 1 BOX	TABLET	1	2
54348-625-20	Sulfamethox-TMP DS	1 in 1 BOX	TABLET	1	2
54348-625-20	Sulfamethox-TMP DS	20 in 1 BOTTLE	TABLET	20	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54348-625	SULFAMETHOX-TMP DS (SULFAMETHOXAZOLE, TRIMETHOPRIM) TABLET [PHARMPAK, INC.]	2	Current NDC, Legacy NDC, 8 package rows	20221011_ede74118-32c5-4f52-9823-509538e674c8.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Amneal Pharmaceuticals LLC	f0e73842-6002-43c2-97fc-0cadc1bf6346	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	AvKARE	9f130443-c8e7-9122-8f27-f72f07f3f29e	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Northwind Health Company, LLC	f2b8e9d9-1274-22ca-e053-2a95a90a6f1a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Cardinal Health 107, LLC	5dc03027-cdaf-461f-87fd-630d382fc723	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Major Pharmaceuticals	abe0d2d5-4879-4b4e-9b57-47ea83a17ba0	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	0aaf1dbe-b69d-43bd-a4ab-69cb27ab417d	2025-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Amneal Pharmaceuticals of New York LLC	3233c54d-484d-4550-b172-db8af47d1b7f	2025-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim DS	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Advanced Rx Pharmacy of Tennessee, LLC	b001e648-2710-3ada-e053-2995a90a52f1	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Bryant Ranch Prepack	a174991a-53e7-c791-3cee-b706a48e0ec5	2024-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	f39a4c93-0a0e-4801-aecc-c55a2fa5e68b	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	ffc5d594-429c-4303-b3b6-f5a83e915b55	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	07a49665-fe2a-4a92-a57e-49db224b012e	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	8661e318-ddf3-4a60-8781-6fa42307c60a	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	b85a58a7-74d6-4629-8027-0cdcbb5c815a	2023-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	A-S Medication Solutions	07da67b1-b50c-4471-8cde-8a119eb8c935	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899
Sulfamethox-TMP DS	SULFAMETHOXAZOLE, TRIMETHOPRIM	PharmPak, Inc.	ede74118-32c5-4f52-9823-509538e674c8	2022-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899 ndc (package): 54348-625-06 ndc (product): 54348-625 ndc11 (package): 54348062506
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Proficient Rx LP	0df74ba1-1aa6-467c-92e7-6b017c7c6bce	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076899 application number: ANDA076899

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	ede74118-32c5-4f52-9823-509538e674c8	2
198335	sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet	SCD	ede74118-32c5-4f52-9823-509538e674c8	2
198335	SMX 800 MG / TMP 160 MG Oral Tablet	SY	ede74118-32c5-4f52-9823-509538e674c8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54348-625-06	54348062506	1 BOTTLE in 1 BOX (54348-625-06) / 6 TABLET in 1 BOTTLE	1 bottle	2019-07-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulfamethoxazole and Trimethoprim Tablets and Double Strength Tablets, USP Rx only	PharmPak, Inc.	2022-10-09	HUMAN PRESCRIPTION DRUG LABEL	2