FDA.reportPublic FDA data

Carisoprodol

Product NDC
71205-704
11-digit product format
712050704
Labeler code
71205
Product ID
71205-704_b04fbd67-9ac5-4043-87e9-c3804d1e5d0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carisoprodol
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040188
Marketing category
ANDA
Marketing start
2020-01-20
Substance
CARISOPRODOL
Active strength
350 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
DEA schedule
CIV
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040188-001CARISOPRODOLCARISOPRODOL350MGTABLET / ORALAA1997-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040188-001AA

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A040188-001CARISOPRODOL350MGTABLET / ORALAA1997-03-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040188-001AA1a50c72e98297…

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarisoprodolCARISOPRODOLREMEDYREPACK INC.b83f7fd1-11e3-4e94-ae53-4637e892b3722026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CARISOPRODOLCARISOPRODOLDirectrxd5cc9f99-59ae-55db-e053-2995a90affb72026-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLA-S Medication Solutions6c15f559-c045-4271-86ef-e001aad39c332026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLA-S Medication Solutions88f9b969-4225-49d6-9e4c-8c397ba7b50c2026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLPD-Rx Pharmaceuticals, Inc.4626a7a7-c433-4dab-8deb-e6e45de493a62025-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLPD-Rx Pharmaceuticals, Inc.9d251c26-c893-425a-b8ac-20c06e50e80c2025-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLBryant Ranch Prepackf8aee817-c652-441e-b99a-8cbc4e6d06ef2025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLBryant Ranch Prepack95e13b8c-3558-43f0-b888-90978db878fb2025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLBryant Ranch Prepackacc7f959-55ac-4d9b-8ef4-4538378364e62025-01-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLOxford Pharmaceuticals, LLC03c3455f-e217-4a7e-908f-609333dc35fc2024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLMedsource Pharmaceuticals125023cb-45c2-1685-e063-6394a90af0892024-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLAphena Pharma Solutions - Tennessee, LLC2484de44-b36a-421c-a4d9-64c2016947542023-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
CarisoprodolCARISOPRODOLProficient Rx LPb04fbd67-9ac5-4043-87e9-c3804d1e5d0c2022-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188
ndc (product): 71205-704
CarisoprodolCARISOPRODOLAphena Pharma Solutions - Tennessee, LLC2179f18b-df15-4bf6-a7c7-6d9960f49a422021-12-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040188
application number: ANDA040188

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARISOPRODOL350 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
21925K482HInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197446Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b04fbd67-9ac5-4043-87e9-c3804d1e5d0cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
780d53a1-1665-e26e-d112-85333c0c8a2eProduct name520220516
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-704-30Carisoprodol30 in 1 BOTTLETABLET301
71205-704-60Carisoprodol60 in 1 BOTTLETABLET601
71205-704-90Carisoprodol90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-704-90EA - Each71205-70436799a75-9c6b-4093-9860-87a1df25ccc712022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-704CARISOPRODOL TABLET [PROFICIENT RX LP]1Current NDC, Legacy NDC, 3 package rows20221005_b04fbd67-9ac5-4043-87e9-c3804d1e5d0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197446carisoprodol 350 MG Oral TabletPSNb04fbd67-9ac5-4043-87e9-c3804d1e5d0c1
197446carisoprodol 350 MG Oral TabletSCDb04fbd67-9ac5-4043-87e9-c3804d1e5d0c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-704-307120507043030 TABLET in 1 BOTTLE (71205-704-30) 30 tablet2022-10-030000-00-00NoNoCurrent
71205-704-607120507046060 TABLET in 1 BOTTLE (71205-704-60) 60 tablet2022-10-030000-00-00NoNoCurrent
71205-704-907120507049090 TABLET in 1 BOTTLE (71205-704-90) 90 tablet2022-10-030000-00-00NoNoCurrent