FDA.reportPublic FDA data

Meperidine Hydrochloride

Product NDC
0054-3545
11-digit product format
000543545
Labeler code
0054
Product ID
0054-3545_677fb454-d83d-4c3c-b095-a58a1c4781b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Meperidine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA088744
Marketing category
ANDA
Marketing start
1985-01-30
Substance
MEPERIDINE HYDROCHLORIDE
Active strength
50 mg/5mL
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Meperidine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEPERIDINE HYDROCHLORIDE50 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN8E7F7Q170
Rxcui861455, 861467, 861479

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
2957211f-7067-d29a-b09d-73e9648715c8Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c245b765-4133-e5fc-aafb-bfde7c2f8a90Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0054-3545-63Meperidine Hydrochloride500 mL in 1 BOTTLESOLUTION50025
0054-3545-63Meperidine Hydrochloride500 mL in 1 BOTTLE, PLASTICSOLUTION5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-3545-63ML - Milliliter0054-35457f4adc67-b3ae-4ea3-ac03-c6ab2029933112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEPERIDINE HYDROCHLORIDEACTIVE INGREDIENTN8E7F7Q170MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]4
MEPERIDINEACTIVE MOIETY9E338QE28FMEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]4
MALTOLINACTIVE INGREDIENT3A9RD92BS4MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EMEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]4
SORBITOLINACTIVE INGREDIENT506T60A25RMEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]4
WATERINACTIVE INGREDIENT059QF0KO0RMEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [ROXANE LABORATORIES, INC]4
meperidine hydrochlorideACTIVE INGREDIENTN8E7F7Q170MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
meperidineACTIVE MOIETY9E338QE28FMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
croscarmellose sodiumINACTIVE INGREDIENTMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
hydrochloric acidINACTIVE INGREDIENTQTT17582CBMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
lactose monohydrateINACTIVE INGREDIENTMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
magnesium stearateINACTIVE INGREDIENT70097M6I30MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
maltolINACTIVE INGREDIENTMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
micro-crystalline celluloseINACTIVE INGREDIENTMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
povidoneINACTIVE INGREDIENTMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
pregelatinized starchINACTIVE INGREDIENTMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
sorbitol solutionINACTIVE INGREDIENTMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
starch (corn)INACTIVE INGREDIENTMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1
waterINACTIVE INGREDIENTMEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-3545MEPERIDINE HYDROCHLORIDE TABLET MEPERIDINE HYDROCHLORIDE SOLUTION [HIKMA PHARMACEUTICALS USA INC.]20Current NDC, Legacy NDC, 1 package rows20240727_15bc51a8-1e24-4d33-9a2f-05a41c29acf0.zip
0054-3545MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) SOLUTION MEPERIDINE HYDROCHLORIDE (MEPERIDINE HYDROCHLORIDE) TABLET [BOEHRINGER INGELHEIM]1Current NDC, Legacy NDC, 1 package rows20060621_9C4F12E5-5E69-44D4-81A5-BD72C375EEF5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861455meperidine HCl 100 MG Oral TabletPSN15bc51a8-1e24-4d33-9a2f-05a41c29acf025
861479meperidine HCl 50 MG in 5 mL Oral SolutionPSN15bc51a8-1e24-4d33-9a2f-05a41c29acf025
861467meperidine HCl 50 MG Oral TabletPSN15bc51a8-1e24-4d33-9a2f-05a41c29acf025
861479meperidine hydrochloride 10 MG/ML Oral SolutionSCD15bc51a8-1e24-4d33-9a2f-05a41c29acf025
861455meperidine hydrochloride 100 MG Oral TabletSCD15bc51a8-1e24-4d33-9a2f-05a41c29acf025
861467meperidine hydrochloride 50 MG Oral TabletSCD15bc51a8-1e24-4d33-9a2f-05a41c29acf025
861479meperidine HCl 50 MG per 5 ML Oral SolutionSY15bc51a8-1e24-4d33-9a2f-05a41c29acf025
861455pethidine hydrochloride 100 MG Oral TabletSY15bc51a8-1e24-4d33-9a2f-05a41c29acf025
861455meperidine HCl 100 MG Oral TabletPSN9c4f12e5-5e69-44d4-81a5-bd72c375eef51
861479meperidine HCl 50 MG in 5 mL Oral SolutionPSN9c4f12e5-5e69-44d4-81a5-bd72c375eef51
861467meperidine HCl 50 MG Oral TabletPSN9c4f12e5-5e69-44d4-81a5-bd72c375eef51
861479meperidine hydrochloride 10 MG/ML Oral SolutionSCD9c4f12e5-5e69-44d4-81a5-bd72c375eef51
861455meperidine hydrochloride 100 MG Oral TabletSCD9c4f12e5-5e69-44d4-81a5-bd72c375eef51
861467meperidine hydrochloride 50 MG Oral TabletSCD9c4f12e5-5e69-44d4-81a5-bd72c375eef51
861479meperidine HCl 50 MG per 5 ML Oral SolutionSY9c4f12e5-5e69-44d4-81a5-bd72c375eef51
861455pethidine hydrochloride 100 MG Oral TabletSY9c4f12e5-5e69-44d4-81a5-bd72c375eef51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-3545-6300054354563500 mL in 1 BOTTLE (0054-3545-63) 500 ml1985-01-300000-00-00NoNoCurrent