FDA.reportPublic FDA data

Meperidine Hydrochloride

Product NDC
42806-050
11-digit product format
428060050
Labeler code
42806
Product ID
42806-050_a2109eab-1e10-4549-adee-0700efae6f3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meperidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
EPIC PHARMA, LLC
Application
ANDA040331
Marketing category
ANDA
Marketing start
2011-05-05
Substance
MEPERIDINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Meperidine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEPERIDINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN8E7F7Q170
Rxcui861455, 861467

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2957211f-7067-d29a-b09d-73e9648715c8Product name120140508
c245b765-4133-e5fc-aafb-bfde7c2f8a90Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-050-01Meperidine Hydrochloride100 in 1 BOTTLETABLET10030
42806-050-30Meperidine Hydrochloride30 in 1 BOTTLETABLET3030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-050-01EA - Each42806-050083c8c03-a151-4341-b5e7-1b83491b1bc812012-07-24
42806-050-30EA - Each42806-050cceee527-afb7-494f-8f9d-c0bb7dfec0a912020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEPERIDINE HYDROCHLORIDEACTIVE INGREDIENTN8E7F7Q170MEPERIDINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]8
MEPERIDINEACTIVE MOIETY9E338QE28FMEPERIDINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEPERIDINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEPERIDINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEPERIDINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEPERIDINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMEPERIDINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-050MEPERIDINE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]27Current NDC, Legacy NDC, 2 package rows20241222_fae5cc34-5917-4445-9516-25f97ffca8db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861455meperidine HCl 100 MG Oral TabletPSNfae5cc34-5917-4445-9516-25f97ffca8db30
861467meperidine HCl 50 MG Oral TabletPSNfae5cc34-5917-4445-9516-25f97ffca8db30
861455meperidine hydrochloride 100 MG Oral TabletSCDfae5cc34-5917-4445-9516-25f97ffca8db30
861467meperidine hydrochloride 50 MG Oral TabletSCDfae5cc34-5917-4445-9516-25f97ffca8db30
861455pethidine hydrochloride 100 MG Oral TabletSYfae5cc34-5917-4445-9516-25f97ffca8db30

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-050-0142806005001100 TABLET in 1 BOTTLE (42806-050-01) 100 tablet2011-05-050000-00-00NoNoCurrent
42806-050-304280600503030 TABLET in 1 BOTTLE (42806-050-30) 30 tablet2020-01-010000-00-00NoNoCurrent