FDA.reportPublic FDA data

Chlorpheniramine Maleate 4 mg

Product NDC
71335-0963
11-digit product format
713350963
Labeler code
71335
Product ID
71335-0963_e33c825b-bb98-458b-b725-95684ffe9f8a
Type
HUMAN OTC DRUG
Nonproprietary name
Chlorpheniramine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-11-01
Substance
CHLORPHENIRAMINE MALEATE
Active strength
4 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Chlorpheniramine Maleate 4 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORPHENIRAMINE MALEATE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV1Q0O9OJ9Z
Rxcui1363309

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0963-12024-05-17C16284748780-11030e365-4b7f-111a-e063-dadaa90a10e2Chlorpheniramine Maleate 4 mg
71335-0963-22024-05-17C16284748780-11030e365-4b7f-111a-e063-dadaa90a10e2Chlorpheniramine Maleate 4 mg
71335-0963-32024-05-17C16284748780-11030e365-4b7f-111a-e063-dadaa90a10e2Chlorpheniramine Maleate 4 mg
71335-0963-42024-05-17C16284748780-11030e365-4b7f-111a-e063-dadaa90a10e2Chlorpheniramine Maleate 4 mg
71335-0963-52024-05-17C16284748780-11030e365-4b7f-111a-e063-dadaa90a10e2Chlorpheniramine Maleate 4 mg
71335-0963-12024-01-30C16284748780-11030e365-4b7f-111a-e063-dadaa90a10e2Chlorpheniramine Maleate 4 mg
71335-0963-22024-01-30C16284748780-11030e365-4b7f-111a-e063-dadaa90a10e2Chlorpheniramine Maleate 4 mg
71335-0963-32024-01-30C16284748780-11030e365-4b7f-111a-e063-dadaa90a10e2Chlorpheniramine Maleate 4 mg
71335-0963-42024-01-30C16284748780-11030e365-4b7f-111a-e063-dadaa90a10e2Chlorpheniramine Maleate 4 mg
71335-0963-52024-01-30C16284748780-11030e365-4b7f-111a-e063-dadaa90a10e2Chlorpheniramine Maleate 4 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0963-1Chlorpheniramine Maleate 4 mg30 in 1 BOTTLETABLET308
71335-0963-2Chlorpheniramine Maleate 4 mg60 in 1 BOTTLETABLET608
71335-0963-3Chlorpheniramine Maleate 4 mg100 in 1 BOTTLETABLET1008
71335-0963-4Chlorpheniramine Maleate 4 mg120 in 1 BOTTLETABLET1208
71335-0963-5Chlorpheniramine Maleate 4 mg40 in 1 BOTTLETABLET408
71335-0963-6Chlorpheniramine Maleate 4 mg24 in 1 BOTTLETABLET248

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0963CHLORPHENIRAMINE MALEATE 4 MG (CHLORPHENIRAMINE MALEATE) TABLET [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 6 package rows20240518_54681242-c861-4415-b5c0-d3ab55b62be1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1363309chlorpheniramine maleate 4 MG Oral TabletPSN54681242-c861-4415-b5c0-d3ab55b62be18
1363309chlorpheniramine maleate 4 MG Oral TabletSCD54681242-c861-4415-b5c0-d3ab55b62be18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0963-17133509630130 TABLET in 1 BOTTLE (71335-0963-1) 30 tablet2018-10-050000-00-00NoNoCurrent
71335-0963-27133509630260 TABLET in 1 BOTTLE (71335-0963-2) 60 tablet2024-05-170000-00-00NoNoCurrent
71335-0963-371335096303100 TABLET in 1 BOTTLE (71335-0963-3) 100 tablet2024-05-170000-00-00NoNoCurrent
71335-0963-471335096304120 TABLET in 1 BOTTLE (71335-0963-4) 120 tablet2024-05-170000-00-00NoNoCurrent
71335-0963-57133509630540 TABLET in 1 BOTTLE (71335-0963-5) 40 tablet2024-05-170000-00-00NoNoCurrent
71335-0963-67133509630624 TABLET in 1 BOTTLE (71335-0963-6) 24 tablet2024-05-17NoNoCurrent