Etodolac

Product NDC
21695-049
11-digit product format
216950049
Labeler code
21695
Product ID
21695-049_db60911a-2bb1-4e8c-baf0-7cf281bf5778
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etodolac
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA075126
Marketing category
ANDA
Marketing start
1999-09-16
Marketing end
0000-00-00
Substance
ETODOLAC
Active strength
300 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bb9faa76-10d1-4b5f-ab9b-d6a26495edb7Product name120250311
0c3d95a8-02c3-425e-810b-2a14408d9a06Product name420250218
24aa5265-325f-0e21-8836-2c9a907c0454Product name220210601

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-049-21Etodolac21 in 1 BOTTLECAPSULE, GELATIN COATED211
21695-049-30Etodolac30 in 1 BOTTLECAPSULE, GELATIN COATED301
21695-049-42Etodolac42 in 1 BOTTLECAPSULE, GELATIN COATED421
21695-049-60Etodolac60 in 1 BOTTLECAPSULE, GELATIN COATED601
21695-049-90Etodolac90 in 1 BOTTLECAPSULE, GELATIN COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-049-21EA - Each21695-049588ebaee-3b7d-425e-b6ab-d107ead6e20812012-07-24
21695-049-30EA - Each21695-04943452b4d-735e-474c-8011-ce70a2f632d712012-07-24
21695-049-42EA - Each21695-04995190804-2fc4-4894-bb05-214d428a25af12012-07-24
21695-049-60EA - Each21695-049a5fe11c5-23ae-4063-ba83-1f07fdab492c12012-07-24
21695-049-90EA - Each21695-049a0c9a494-be73-4d4b-934d-3ed6cdc49c3612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EtodolacACTIVE INGREDIENT2M36281008ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]1
EtodolacACTIVE MOIETY2M36281008ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]1
gelatinINACTIVE INGREDIENT2G86QN327LETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]1
talcINACTIVE INGREDIENT7SEV7J4R1UETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-049ETODOLAC CAPSULE, GELATIN COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 5 package rows20110916_db60911a-2bb1-4e8c-baf0-7cf281bf5778.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197685etodolac 300 MG Oral CapsulePSNdb60911a-2bb1-4e8c-baf0-7cf281bf57781
197685etodolac 300 MG Oral CapsuleSCDdb60911a-2bb1-4e8c-baf0-7cf281bf57781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-049-212169500492121 in 1 BOTTLEHistorical
21695-049-302169500493030 in 1 BOTTLEHistorical
21695-049-422169500494242 in 1 BOTTLEHistorical
21695-049-602169500496060 in 1 BOTTLEHistorical
21695-049-902169500499090 in 1 BOTTLEHistorical