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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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