Bactrim

Product NDC
49708-145
11-digit product format
497080145
Labeler code
49708
Product ID
49708-145_2a76a544-1f84-4b42-e063-6394a90a08d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc
Application
NDA017377
Marketing category
NDA
Marketing start
2004-11-01
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
400; 80 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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017377-001BACTRIMSULFAMETHOXAZOLE; TRIMETHOPRIM400MG;80MGTABLET / ORALABRLD, Approved before 1982
N017377-002BACTRIM DSSULFAMETHOXAZOLE; TRIMETHOPRIM800MG;160MGTABLET / ORALABRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N017377-001AB
N017377-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N017377-001BACTRIM400MG;80MGTABLET / ORALABRLD, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N017377-002BACTRIM DS800MG;160MGTABLET / ORALABRLD, RS, Approved before 198284e616aacf4f…
2026-08-18 06:07:402026-07N017377-001BACTRIM400MG;80MGTABLET / ORALABRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N017377-002BACTRIM DS800MG;160MGTABLET / ORALABRLD, RS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017377-001BACTRIM400MG;80MGTABLET / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017377-002BACTRIM DS800MG;160MGTABLET / ORALABRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017377-001BACTRIM400MG;80MGTABLET / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017377-002BACTRIM DS800MG;160MGTABLET / ORALABRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017377-001BACTRIM400MG;80MGTABLET / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017377-002BACTRIM DS800MG;160MGTABLET / ORALABRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017377-001BACTRIM400MG;80MGTABLET / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017377-002BACTRIM DS800MG;160MGTABLET / ORALABRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017377-001BACTRIM400MG;80MGTABLET / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017377-002BACTRIM DS800MG;160MGTABLET / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017377-001BACTRIM400MG;80MGTABLET / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017377-002BACTRIM DS800MG;160MGTABLET / ORALABRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017377-001BACTRIM400MG;80MGTABLET / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017377-002BACTRIM DS800MG;160MGTABLET / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017377-001BACTRIM400MG;80MGTABLET / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017377-002BACTRIM DS800MG;160MGTABLET / ORALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017377-001BACTRIM400MG;80MGTABLET / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017377-002BACTRIM DS800MG;160MGTABLET / ORALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017377-001BACTRIM400MG;80MGTABLET / ORALABRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N017377-002BACTRIM DS800MG;160MGTABLET / ORALABRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017377-001BACTRIM400MG;80MGTABLET / ORALABRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017377-002BACTRIM DS800MG;160MGTABLET / ORALABRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017377-001BACTRIM400MG;80MGTABLET / ORALABRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017377-002BACTRIM DS800MG;160MGTABLET / ORALABRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017377-001BACTRIM400MG;80MGTABLET / ORALABRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017377-002BACTRIM DS800MG;160MGTABLET / ORALABRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017377-001BACTRIM400MG;80MGTABLET / ORALABRLD, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N017377-002BACTRIM DS800MG;160MGTABLET / ORALABRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017377-001BACTRIM400MG;80MGTABLET / ORALABRLD, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017377-002BACTRIM DS800MG;160MGTABLET / ORALABRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017377-001BACTRIM400MG;80MGTABLET / ORALABRLD, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N017377-002BACTRIM DS800MG;160MGTABLET / ORALABRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017377-001BACTRIM400MG;80MGTABLET / ORALABRLD, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N017377-002BACTRIM DS800MG;160MGTABLET / ORALABRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017377-001BACTRIM400MG;80MGTABLET / ORALABRLD, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N017377-002BACTRIM DS800MG;160MGTABLET / ORALABRLD, RS, Approved before 198274a2ff9319b5…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N017377-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N017377-002AB184e616aacf4f…
2026-08-18 06:07:402026-07N017377-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N017377-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017377-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N017377-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017377-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017377-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017377-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N017377-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017377-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017377-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017377-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017377-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017377-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017377-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017377-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017377-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017377-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017377-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017377-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017377-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017377-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N017377-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017377-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017377-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017377-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017377-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017377-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017377-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017377-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N017377-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017377-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017377-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017377-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N017377-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017377-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N017377-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017377-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N017377-002AB174a2ff9319b5…

Additional Listing Data#

Finished product
Yes
Brand name base
Bactrim
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFAMETHOXAZOLE400 mg/1
TRIMETHOPRIM80 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
AN164J8Y0XInternal UNII lookup
JE42381TNVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198334Internal RxNorm lookup
198335Internal RxNorm lookup
208416Internal RxNorm lookup
849580Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f59d0c04-9c66-4d53-a0e1-cb55570deb62Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ce811b5-329e-27f8-b5ff-66d52b435c00Product name320240108
8d30c4f0-0228-cea4-e3aa-f19064c47f27Product name320221128
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49708-145-01Bactrim100 in 1 BOTTLE, PLASTICTABLET10018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49708-145-01EA - Each49708-1455fd313dd-5ab7-448c-b95b-3d77baa66d2a12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sulfamethoxazoleACTIVE INGREDIENTJE42381TNVBACTRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [CARACO PHARMA, INC.]2
TrimethoprimACTIVE INGREDIENTAN164J8Y0XBACTRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [CARACO PHARMA, INC.]2
sulfamethoxazoleACTIVE MOIETYJE42381TNVBACTRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [CARACO PHARMA, INC.]2
TrimethoprimACTIVE MOIETYAN164J8Y0XBACTRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [CARACO PHARMA, INC.]2
Docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0BACTRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [CARACO PHARMA, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30BACTRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [CARACO PHARMA, INC.]2
Sodium benzoateINACTIVE INGREDIENTOJ245FE5EUBACTRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [CARACO PHARMA, INC.]2
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2BACTRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [CARACO PHARMA, INC.]2
starch, cornINACTIVE INGREDIENTO8232NY3SJBACTRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [CARACO PHARMA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49708-145BACTRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC]18Current NDC, Legacy NDC, 1 package rows20250101_f59d0c04-9c66-4d53-a0e1-cb55570deb62.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BactrimSULFAMETHOXAZOLE AND TRIMETHOPRIMSun Pharmaceutical Industries, Incf59d0c04-9c66-4d53-a0e1-cb55570deb622024-12-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 017377
application number: NDA017377
ndc (product): 49708-145

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
208416Bactrim 400 MG /80 MG Oral TabletPSNf59d0c04-9c66-4d53-a0e1-cb55570deb6218
849580Bactrim DS 800 MG/ 160 MG Oral TabletPSNf59d0c04-9c66-4d53-a0e1-cb55570deb6218
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletPSNf59d0c04-9c66-4d53-a0e1-cb55570deb6218
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSNf59d0c04-9c66-4d53-a0e1-cb55570deb6218
208416sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet [Bactrim]SBDf59d0c04-9c66-4d53-a0e1-cb55570deb6218
849580sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet [Bactrim]SBDf59d0c04-9c66-4d53-a0e1-cb55570deb6218
198334sulfamethoxazole 400 MG / trimethoprim 80 MG Oral TabletSCDf59d0c04-9c66-4d53-a0e1-cb55570deb6218
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCDf59d0c04-9c66-4d53-a0e1-cb55570deb6218
208416Bactrim 400 MG / 80 MG Oral TabletSYf59d0c04-9c66-4d53-a0e1-cb55570deb6218
849580Bactrim DS 800 MG / 160 MG Oral TabletSYf59d0c04-9c66-4d53-a0e1-cb55570deb6218
198334SMX 400 MG / TMP 80 MG Oral TabletSYf59d0c04-9c66-4d53-a0e1-cb55570deb6218
208416SMX 400 MG / TMP 80 MG Oral Tablet [Bactrim]SYf59d0c04-9c66-4d53-a0e1-cb55570deb6218
198335SMX 800 MG / TMP 160 MG Oral TabletSYf59d0c04-9c66-4d53-a0e1-cb55570deb6218
849580SMX 800 MG / TMP 160 MG Oral Tablet [Bactrim]SYf59d0c04-9c66-4d53-a0e1-cb55570deb6218

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49708-145-0149708014501100 TABLET in 1 BOTTLE, PLASTIC (49708-145-01) 100 tablet2004-11-010000-00-00NoNoCurrent