Sulfamethoxazole and Trimethoprim

Product NDC: 62135-873
Requested package NDC: 62135-873-24
11-digit product format: 621350873
Labeler code: 62135
Product ID: 62135-873_316d17d0-4fb7-a200-e063-6394a90aa5e2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sulfamethoxazole and Trimethoprim
Dosage form: SUSPENSION
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA077785
Marketing category: ANDA
Marketing start: 2007-01-24
Substance: SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength: 800; 160 mg/20mL; mg/20mL
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 43.

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 · 43 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	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077785-001	SULFAMETHOXAZOLE AND TRIMETHOPRIM	200MG/5ML;40MG/5ML	SUSPENSION / ORAL	AB	2007-01-24	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A077785-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077785-001	AB	1	`caaa826d4ba7…`
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…`

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: Sulfamethoxazole and Trimethoprim
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SULFAMETHOXAZOLE	800 mg/20mL
TRIMETHOPRIM	160 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313134	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
b5b7aba5-f93d-46bc-a3c2-712de1c5cff3	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
62135-873-24	Sulfamethoxazole and Trimethoprim	2 in 1 BOX	SUSPENSION	2	5
62135-873-24	Sulfamethoxazole and Trimethoprim	10 in 1 TRAY	SUSPENSION	10	5
62135-873-52	Sulfamethoxazole and Trimethoprim	20 mL in 1 CUP	SUSPENSION	20	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-873-24	ML - Milliliter	62135-873	d1d33c88-88a7-42aa-8056-3b03426afd4b	1	2024-09-09
62135-873-52	ML - Milliliter	62135-873	5193a7a8-0a13-4266-8835-738c899765a7	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-873	SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [CHARTWELL RX, LLC]	5	Current NDC, 3 package rows	20250331_b5b7aba5-f93d-46bc-a3c2-712de1c5cff3.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 ndc (package): 62135-873-24 ndc (product): 62135-873 ndc11 (package): 62135087324

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	b5b7aba5-f93d-46bc-a3c2-712de1c5cff3	5
313134	sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral Suspension	SCD	b5b7aba5-f93d-46bc-a3c2-712de1c5cff3	5
313134	SMX 40 MG/ML / TMP 8 MG/ML Oral Suspension	SY	b5b7aba5-f93d-46bc-a3c2-712de1c5cff3	5
313134	sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral Suspension	SY	b5b7aba5-f93d-46bc-a3c2-712de1c5cff3	5
313134	sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral Suspension	SY	b5b7aba5-f93d-46bc-a3c2-712de1c5cff3	5
313134	sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral Suspension	SY	b5b7aba5-f93d-46bc-a3c2-712de1c5cff3	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62135-873-24	62135087324	2 TRAY in 1 BOX (62135-873-24) / 10 CUP in 1 TRAY / 20 mL in 1 CUP (62135-873-52)	2 tray	2024-05-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sulfamethoxazole and Trimethoprim Oral Suspension Rx Only	Chartwell RX, LLC	2025-03-28	HUMAN PRESCRIPTION DRUG LABEL	5