NDC 31722-005-32 - Mesalamine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
31722-005
Requested NDC
31722-005-32
Package NDCs from labels
31722-005-32, 31722-005-30, 31722-005-31
Manufacturer
Camber Pharmaceuticals, Inc. | Annora Pharma Private Limited
Effective date
2024-02-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mesalamine - Camber Pharmaceuticals, Inc. | Annora Pharma Private LimitedCamber Pharmaceuticals, Inc. | Annora Pharma Private Limited2024-02-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-005-30Mesalamine5 in 1 CARTONSUPPOSITORY54
31722-005-31Mesalamine7 in 1 CARTONSUPPOSITORY74
31722-005-32Mesalamine6 in 1 PACKAGESUPPOSITORY64

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-005MESALAMINE (MESALAMINE) SUPPOSITORY [CAMBER PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 3 package rows20240228_efa9d039-ae1f-4cd6-98f2-e87a901dfaeb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-005-30EA - Each31722-005280c6a2e-f10e-44c7-acb8-89fcda18781e12020-09-14
31722-005-32EA - Each31722-005d00e030e-2fbc-477d-9788-c2974507514512020-09-14

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 3 of 3 · 59 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MesalamineMESALAMINEBryant Ranch Prepack06792d20-d7e9-4b66-a4cb-cd0cf1a2db252024-06-28Warnings, Adverse reactionsExact identifier
rxcui: 248420
unii: 4Q81I59GXC
MesalamineMESALAMINERising Pharma Holdings, Inc.de981df1-747a-480d-a866-e72332a1544d2024-06-14Warnings, Adverse reactionsExact identifier
rxcui: 248420
unii: 4Q81I59GXC
MESALAMINEMESALAMINEBryant Ranch Prepack063ca661-1b5c-4941-a5b9-5dd0fa46b3d02024-05-29Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEAmneal Pharmaceuticals LLC00f77203-3615-47e8-ae25-6e1cf8a2a00a2024-05-23Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEBryant Ranch Prepackc9b1ef9d-1d06-48e7-87d2-7985b99124a62024-05-01Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
mesalamineMESALAMINEGolden State Medical Supply, Inc.170657d1-1f32-f036-e063-6294a90a4ed42024-04-26Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MESALAMINEMESALAMINELannett Company Inc.29dbe417-15a9-4c4d-846b-81cabda7ac702024-02-29Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINECamber Pharmaceuticals, Inc.efa9d039-ae1f-4cd6-98f2-e87a901dfaeb2024-02-26Warnings, Adverse reactionsExact identifier
application number: ANDA213377
ndc (package): 31722-005-32
ndc (package): 31722-005-30
ndc (package): 31722-005-31
ndc (product): 31722-005
ndc11 (package): 31722000532
rxcui: 248420
spl id: 1248c2d3-b241-5551-e063-6294a90a2f4e
spl set id: efa9d039-ae1f-4cd6-98f2-e87a901dfaeb
unii: 4Q81I59GXC
MesalamineMESALAMINECamber Pharmaceuticals, Inc.04ce2182-2e8c-4598-a269-550cfaddde6c2024-02-15Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEANI Pharmaceuticals, Inc.3cf751f2-a0c9-45d7-8acb-2bc61db0e4ac2024-02-14Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEAurobindo Pharma Limitedd6c0fc76-644e-4301-9672-f432061e3d372024-01-20Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MESALAMINEMESALAMINEAlembic Pharmaceuticals Inc.87d3d62d-2dc3-4e6f-be33-cabbca12e8f72024-01-09Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
mesalamineMESALAMINETeva Pharmaceuticals USA, Inc.8d27a608-3ba1-4799-be38-c00fb08ce3ce2023-12-19Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
Mesalamine RectalMESALAMINEAmring Pharmaceuticals Inc.87de237c-febb-42ca-b2a4-b444396f86402023-12-15Warnings, Adverse reactionsExact identifier
rxcui: 248420
unii: 4Q81I59GXC
MesalamineMESALAMINESun Pharmaceutical Industries, Inc.fd8b02de-7dfa-444d-a1f8-1436b578e0cb2023-12-01Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEMylan Pharmaceuticals Inc.c8b93ea3-0367-4605-b87f-06c3812ff3b72023-11-30Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MesalamineMESALAMINEZydus Pharmaceuticals USA Inc.cd8493f7-91fd-4c2d-b3d7-c1301825586b2023-10-26Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
mesalamineMESALAMINEZydus Pharmaceuticals USA Inc.533bfaf5-0add-4b49-a4f2-ddea2b83f65d2023-10-26Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC
MESALAMINEMESALAMINEAlembic Pharmaceuticals Limited4ef59b85-e5a5-479f-a1fe-e1cee4d876702022-11-07Warnings, Adverse reactionsExact identifier
unii: 4Q81I59GXC

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.