FDA.reportPublic FDA data

Paregoric

Product NDC
50383-855
11-digit product format
503830855
Labeler code
50383
Product ID
50383-855_e20d67f8-2036-4a41-89b7-81fc6cbf83d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paregoric
Dosage form
LIQUID
Route
ORAL
Labeler
Hi-Tech Pharmacal Co., Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2012-08-06
Marketing end
0000-00-00
Substance
MORPHINE
Active strength
2 mg/5mL
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89941d4c-522d-cee0-b273-43cfa7ef6d35Product name420250516
f15f9e76-db42-8a50-218a-5ef5affa58daProduct name420240216
944b0689-73f4-6a2f-c654-1180896353c0Product name420220210
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
67e166c6-23d4-4709-b77d-5ca6182dcae0Product name120180830
c573a64c-fe17-2eac-fbcb-788868b4ff6bProduct name920180619
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
7c1819cf-69a0-41dc-aeaa-a820729bc959Product name120170406
7a68fc31-10e5-df04-67e0-3a613a2d4d2eProduct name520161114
175682a8-c657-45a2-9dfb-c565306b03c8Product name120160112
b73dadd0-1b4a-4f88-956f-a2be216c8fadProduct name120151123
4c272b1c-87fc-ebc0-994d-ac28b1e0416eProduct name120140508
7a537f54-d322-5e54-a3a2-035d3e21c3c6Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-855-162020-01-31C16284748780-19d75b9d0-c41e-f424-e053-dadaa90a57ceParegoric, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-855-16Paregoric473 mL in 1 BOTTLELIQUID47310

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-855-16ML - Milliliter50383-8551bdbddfb-bfb8-4e19-b693-f4ada09ecb7e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MORPHINEACTIVE INGREDIENT76I7G6D29CPAREGORIC LIQUID [HI-TECH PHARMACAL CO., INC.]3
MORPHINEACTIVE MOIETY76I7G6D29CPAREGORIC LIQUID [HI-TECH PHARMACAL CO., INC.]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MPAREGORIC LIQUID [HI-TECH PHARMACAL CO., INC.]3
ANISE OILINACTIVE INGREDIENT6Y89129C8HPAREGORIC LIQUID [HI-TECH PHARMACAL CO., INC.]3
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMPAREGORIC LIQUID [HI-TECH PHARMACAL CO., INC.]3
CAMPHOR OILINACTIVE INGREDIENT75IZZ8Y727PAREGORIC LIQUID [HI-TECH PHARMACAL CO., INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPAREGORIC LIQUID [HI-TECH PHARMACAL CO., INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RPAREGORIC LIQUID [HI-TECH PHARMACAL CO., INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-855PAREGORIC LIQUID [HI-TECH PHARMACAL CO., INC.]10Legacy NDC, 1 package rows20181214_405b7997-1e47-4904-96d0-72c241ed8195.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200240paregoric 2 MG (as morphine equivalent) in 5 mL Oral SolutionPSN405b7997-1e47-4904-96d0-72c241ed819510
200240paregoric 0.4 MG/ML Oral SolutionSCD405b7997-1e47-4904-96d0-72c241ed819510
200240paregoric 2 MG (as morphine equivalent) per 5 ML Oral SolutionSY405b7997-1e47-4904-96d0-72c241ed819510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50383-855-1650383085516473 mL in 1 BOTTLE473 mlHistorical