SEROMYCIN

Product NDC
13845-1200
11-digit product format
138451200
Labeler code
13845
Product ID
13845-1200_b67c1b1d-7687-427a-a07a-e8100c046f73
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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13845-1200-32024-07-30C16284748780-11030e365-428e-111a-e063-dadaa90a10e2e1e08327-4b90-463e-bb2a-22438cabcef2
13845-1200-32024-01-30C16284748780-11030e365-428e-111a-e063-dadaa90a10e2e1e08327-4b90-463e-bb2a-22438cabcef2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13845-1200-1SEROMYCIN250 mg in 1 CAPSULECAPSULE2505
13845-1200-3SEROMYCIN40 in 1 BOTTLECAPSULE405

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13845-1200-3EA - Each13845-12000fb3473d-33f2-4cdc-9004-6d1d0c6a770112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOSERINEACTIVE INGREDIENT95IK5KI84ZSEROMYCIN (CYCLOSERINE) CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
CYCLOSERINEACTIVE MOIETY95IK5KI84ZSEROMYCIN (CYCLOSERINE) CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSEROMYCIN (CYCLOSERINE) CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8SEROMYCIN (CYCLOSERINE) CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSEROMYCIN (CYCLOSERINE) CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSEROMYCIN (CYCLOSERINE) CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYSEROMYCIN (CYCLOSERINE) CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SEROMYCIN (CYCLOSERINE) CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SEROMYCIN (CYCLOSERINE) CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
GELATININACTIVE INGREDIENT2G86QN327LSEROMYCIN (CYCLOSERINE) CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSEROMYCIN (CYCLOSERINE) CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSEROMYCIN (CYCLOSERINE) CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSEROMYCIN (CYCLOSERINE) CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INSEROMYCIN (CYCLOSERINE) CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSEROMYCIN (CYCLOSERINE) CAPSULE [PURDUE GMP CENTER LLC DBA THE CHAO CENTER]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13845-1200SEROMYCIN (CYCLOSERINE) CAPSULE [PARSOLEX GMP CENTER, INC.]5Legacy NDC, 2 package rows20230208_e1e08327-4b90-463e-bb2a-22438cabcef2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197551cycloSERINE 250 MG Oral CapsulePSNe1e08327-4b90-463e-bb2a-22438cabcef25
212797Seromycin 250 MG Oral CapsulePSNe1e08327-4b90-463e-bb2a-22438cabcef25
212797cycloserine 250 MG Oral Capsule [Seromycin]SBDe1e08327-4b90-463e-bb2a-22438cabcef25
197551cycloserine 250 MG Oral CapsuleSCDe1e08327-4b90-463e-bb2a-22438cabcef25
212797Seromycin 250 MG Oral CapsuleSYe1e08327-4b90-463e-bb2a-22438cabcef25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13845-1200-113845120001250 mg in 1 CAPSULE250 mgHistorical
13845-1200-31384512000340 CAPSULE in 1 BOTTLE (13845-1200-3) > 250 mg in 1 CAPSULE (13845-1200-1) 40 capsule2009-03-010000-00-00NoNoCurrent