FDA.reportPublic FDA data

MEPERIDINE HYDROCHLORIDE

Product NDC
0641-6054
11-digit product format
006416054
Labeler code
0641
Product ID
0641-6054_9566d54d-7343-4695-94ff-8b5f2d384c81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MEPERIDINE HYDROCHLORIDE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA080445
Marketing category
ANDA
Marketing start
1975-01-22
Substance
MEPERIDINE HYDROCHLORIDE
Active strength
100 mg/mL
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 HYDROCHLORIDE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN8E7F7Q170
Rxcui861476, 1665685, 1665697

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
2957211f-7067-d29a-b09d-73e9648715c8Product name120140508
c245b765-4133-e5fc-aafb-bfde7c2f8a90Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6054-01MEPERIDINE HYDROCHLORIDE1 mL in 1 VIALINJECTION111
0641-6054-25MEPERIDINE HYDROCHLORIDE25 in 1 CARTONINJECTION2511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6054-01ML - Milliliter0641-6054484e37bd-190d-49d2-b320-b6bd6e41859d12012-07-24
0641-6054-25ML - Milliliter0641-6054e707c7bf-e5c7-492b-bff3-b00283eb4fcc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEPERIDINE HYDROCHLORIDEACTIVE INGREDIENTN8E7F7Q170MEPERIDINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
MEPERIDINEACTIVE MOIETY9E338QE28FMEPERIDINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PMEPERIDINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BMEPERIDINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
WATERINACTIVE INGREDIENT059QF0KO0RMEPERIDINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6054MEPERIDINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]11Current NDC, Legacy NDC, 2 package rows20240410_e0e998da-f056-4fce-be8e-ed60cf3b461b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1665685meperidine HCl 100 MG in 1 ML InjectionPSNe0e998da-f056-4fce-be8e-ed60cf3b461b11
861476meperidine HCl 25 MG in 1 ML InjectionPSNe0e998da-f056-4fce-be8e-ed60cf3b461b11
1665697meperidine HCl 50 MG in 1 ML InjectionPSNe0e998da-f056-4fce-be8e-ed60cf3b461b11
16656851 ML meperidine hydrochloride 100 MG/ML InjectionSCDe0e998da-f056-4fce-be8e-ed60cf3b461b11
8614761 ML meperidine hydrochloride 25 MG/ML InjectionSCDe0e998da-f056-4fce-be8e-ed60cf3b461b11
16656971 ML meperidine hydrochloride 50 MG/ML InjectionSCDe0e998da-f056-4fce-be8e-ed60cf3b461b11
1665685meperidine HCl 100 MG per 1 ML InjectionSYe0e998da-f056-4fce-be8e-ed60cf3b461b11
861476meperidine HCl 25 MG per 1 ML InjectionSYe0e998da-f056-4fce-be8e-ed60cf3b461b11
1665697meperidine HCl 50 MG per 1 ML InjectionSYe0e998da-f056-4fce-be8e-ed60cf3b461b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6054-01006416054011 mL in 1 VIAL1 mlHistorical
0641-6054-250064160542525 VIAL in 1 CARTON (0641-6054-25) / 1 mL in 1 VIAL (0641-6054-01) 25 vial1975-01-220000-00-00NoNoCurrent