Sulfamethoxazole and Trimethoprim

Product NDC: 17856-5181
Requested package NDC: 17856-5181-3
11-digit product format: 178565181
Labeler code: 17856
Product ID: 17856-5181_4b1ecd4a-5752-4ef8-8946-2abcb60e86ab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfamethoxazole and Trimethoprim
Dosage form: SUSPENSION
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA077785
Marketing category: ANDA
Marketing start: 2007-01-24
Marketing end: 0000-00-00
Substance: SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength: 200 mg/5mL; mg/5mL
Pharmacologic classes: Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	17856-5181	17856-5181-3	I	Inactivated by FDA		2026-08-11

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	SULFAMETHOXAZOLE; TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB		2007-01-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077785-001	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 2 · 41 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	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A077785-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077785-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077785-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077785-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077785-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077785-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077785-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077785-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077785-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077785-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077785-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077785-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077785-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077785-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077785-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077785-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077785-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077785-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077785-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077785-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077785-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077785-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077785-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077785-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077785-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077785-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077785-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077785-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077785-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077785-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077785-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077785-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077785-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077785-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077785-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077785-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077785-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077785-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077785-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077785-001	AB	1	`cb3db0bc1861…`

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17856-5181-1	2022-01-28	C162847	48780-1	d6a99b39-647a-a426-e053-dadaa90af4c2	Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg/40 mg per 5 mL Rx only
17856-5181-2	2022-01-28	C162847	48780-1	d6a99b39-647a-a426-e053-dadaa90af4c2	Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg/40 mg per 5 mL Rx only
17856-5181-3	2022-01-28	C162847	48780-1	d6a99b39-647a-a426-e053-dadaa90af4c2	Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg/40 mg per 5 mL Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17856-5181-1	Sulfamethoxazole and Trimethoprim	5 mL in 1 CUP, UNIT-DOSE	SUSPENSION	5	1
17856-5181-1	Sulfamethoxazole and Trimethoprim	72 in 1 BOX, UNIT-DOSE	SUSPENSION	72	1
17856-5181-2	Sulfamethoxazole and Trimethoprim	10 mL in 1 CUP, UNIT-DOSE	SUSPENSION	10	1
17856-5181-2	Sulfamethoxazole and Trimethoprim	72 in 1 BOX, UNIT-DOSE	SUSPENSION	72	1
17856-5181-3	Sulfamethoxazole and Trimethoprim	20 mL in 1 CUP, UNIT-DOSE	SUSPENSION	20	1
17856-5181-3	Sulfamethoxazole and Trimethoprim	50 in 1 BOX, UNIT-DOSE	SUSPENSION	50	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-5181	SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORP.]	1	Legacy NDC, 6 package rows	20201028_e2a018ad-31aa-47d2-b96b-e7a1deee0976.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	Chartwell Governmental & Specialty RX, LLC.	2a5173ba-047d-4a80-81fb-7154265ae3d1	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077785 application number: ANDA077785
Sulfamethoxazole and Trimethoprim	SULFAMETHOXAZOLE AND TRIMETHOPRIM	Chartwell RX, LLC	b5b7aba5-f93d-46bc-a3c2-712de1c5cff3	2025-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077785 application number: ANDA077785

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
313134	sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral Suspension	PSN	e2a018ad-31aa-47d2-b96b-e7a1deee0976	1
313134	sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral Suspension	SCD	e2a018ad-31aa-47d2-b96b-e7a1deee0976	1
313134	SMX 40 MG/ML / TMP 8 MG/ML Oral Suspension	SY	e2a018ad-31aa-47d2-b96b-e7a1deee0976	1
313134	sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral Suspension	SY	e2a018ad-31aa-47d2-b96b-e7a1deee0976	1
313134	sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral Suspension	SY	e2a018ad-31aa-47d2-b96b-e7a1deee0976	1
313134	sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral Suspension	SY	e2a018ad-31aa-47d2-b96b-e7a1deee0976	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-5181-3	17856518103	50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-5181-3) > 20 mL in 1 CUP, UNIT-DOSE	2020-10-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg/40 mg per 5 mL Rx only	ATLANTIC BIOLOGICALS CORP.	2020-10-27	HUMAN PRESCRIPTION DRUG LABEL	1