CYCLOSERINE

Product NDC
13845-1201
11-digit product format
138451201
Labeler code
13845
Product ID
13845-1201_1d21c18e-a54d-4c62-9c3b-ee0912a50950
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CYCLOSERINE
Dosage form
CAPSULE
Route
ORAL
Labeler
Parsolex Gmp Center, Inc.
Application
ANDA060593
Marketing category
ANDA
Marketing start
2009-03-01
Marketing end
0000-00-00
Substance
CYCLOSERINE
Active strength
250 mg/250mg
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13845-1201-32024-07-30C16284748780-11030e365-66a0-111a-e063-dadaa90a10e210727aa8-a03e-4b61-9a80-a024cb4a2d28
13845-1201-32024-01-30C16284748780-11030e365-66a0-111a-e063-dadaa90a10e210727aa8-a03e-4b61-9a80-a024cb4a2d28

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13845-1201-1CYCLOSERINE250 mg in 1 CAPSULECAPSULE2505
13845-1201-3CYCLOSERINE40 in 1 BOTTLECAPSULE405

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13845-1201-3EA - Each13845-120181a0cff9-63b1-48ea-9dda-b7ac55195bb812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOSERINEACTIVE INGREDIENT95IK5KI84ZCYCLOSERINE CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
CYCLOSERINEACTIVE MOIETY95IK5KI84ZCYCLOSERINE CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCYCLOSERINE CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CYCLOSERINE CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCYCLOSERINE CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCYCLOSERINE CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYCYCLOSERINE CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CYCLOSERINE CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CYCLOSERINE CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
GELATININACTIVE INGREDIENT2G86QN327LCYCLOSERINE CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCYCLOSERINE CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCYCLOSERINE CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCYCLOSERINE CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INCYCLOSERINE CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOSERINE CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13845-1201CYCLOSERINE CAPSULE [PARSOLEX GMP CENTER, INC.]5Legacy NDC, 2 package rows20230120_10727aa8-a03e-4b61-9a80-a024cb4a2d28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197551cycloSERINE 250 MG Oral CapsulePSN10727aa8-a03e-4b61-9a80-a024cb4a2d285
197551cycloserine 250 MG Oral CapsuleSCD10727aa8-a03e-4b61-9a80-a024cb4a2d285

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13845-1201-113845120101250 mg in 1 CAPSULE250 mgHistorical
13845-1201-31384512010340 CAPSULE in 1 BOTTLE (13845-1201-3) > 250 mg in 1 CAPSULE (13845-1201-1) 40 capsule2009-03-010000-00-00NoNoCurrent