FDA.reportPublic FDA data

Oxazepam

Product NDC
67544-117
11-digit product format
675440117
Labeler code
67544
Product ID
67544-117_166ba137-98a4-4072-90e1-ab7b6248a351
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxazepam
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA072251
Marketing category
ANDA
Marketing start
2007-01-02
Marketing end
0000-00-00
Substance
OXAZEPAM
Active strength
10 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
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
0bf93631-d4c9-1bc6-b689-709626127556Product name220251210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67544-117-302023-01-30C16284748780-1f386c64a-4106-0266-e053-dadaa90a7c1aOXAZEPAM CAPSULES, USP
67544-117-532023-01-30C16284748780-1f386c64a-4106-0266-e053-dadaa90a7c1aOXAZEPAM CAPSULES, USP
67544-117-602023-01-30C16284748780-1f386c64a-4106-0266-e053-dadaa90a7c1aOXAZEPAM CAPSULES, USP
67544-117-702023-01-30C16284748780-1f386c64a-4106-0266-e053-dadaa90a7c1aOXAZEPAM CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-117-30Oxazepam30 in 1 BOTTLE, PLASTICCAPSULE, GELATIN COATED303
67544-117-53Oxazepam60 in 1 BOTTLE, PLASTICCAPSULE, GELATIN COATED603
67544-117-60Oxazepam90 in 1 BOTTLE, PLASTICCAPSULE, GELATIN COATED903
67544-117-70Oxazepam120 in 1 BOTTLE, PLASTICCAPSULE, GELATIN COATED1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-117-30EA - Each67544-1177e62f887-9679-491b-8187-c762f94064b112014-05-02
67544-117-53EA - Each67544-117d91900d4-30a1-4dc3-9187-8c8751399c2312014-05-02
67544-117-60EA - Each67544-117ec0a3698-0758-4a0d-bb0b-0780fa329c0c12014-05-02
67544-117-70EA - Each67544-117c421d610-6778-4d19-8be1-40e114b575b612014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXAZEPAMACTIVE INGREDIENT6GOW6DWN2AOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
OXAZEPAMACTIVE MOIETY6GOW6DWN2AOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
GELATININACTIVE INGREDIENT2G86QN327LOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-117OXAZEPAM CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC, 4 package rows20191224_3bccbfa9-fdcf-44c3-86f5-028ca92223ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198057oxazepam 10 MG Oral CapsulePSN3bccbfa9-fdcf-44c3-86f5-028ca92223ca3
312134oxazepam 15 MG Oral CapsulePSN3bccbfa9-fdcf-44c3-86f5-028ca92223ca3
198057oxazepam 10 MG Oral CapsuleSCD3bccbfa9-fdcf-44c3-86f5-028ca92223ca3
312134oxazepam 15 MG Oral CapsuleSCD3bccbfa9-fdcf-44c3-86f5-028ca92223ca3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67544-117-306754401173030 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (67544-117-30) 2007-02-010000-00-00NoNoCurrent
67544-117-536754401175360 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (67544-117-53) 2007-01-180000-00-00NoNoCurrent
67544-117-606754401176090 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (67544-117-60) 2007-01-220000-00-00NoNoCurrent
67544-117-7067544011770120 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (67544-117-70) 2007-02-270000-00-00NoNoCurrent