Erythromycin

Product NDC
52959-301
11-digit product format
529590301
Labeler code
52959
Product ID
52959-301_78d48e3a-2b53-489c-8961-3444d25a4a6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
H.J. Harkins Company, Inc.
Application
ANDA064067
Marketing category
ANDA
Marketing start
1994-07-29
Marketing end
0000-00-00
Substance
ERYTHROMYCIN
Active strength
5 mg/g
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [CS]
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
d329c2e1-5ae8-4e64-aea0-77ecea3fa1abProduct name320250717
3b331500-3b74-bd2b-fede-d46839f2f4d5Product name620240313
fdae2630-eae0-4769-abfd-8f33d5b771b4Product name320240202
8c898317-b543-1e4e-254f-84cec2f3f57eProduct name220191002
64ae94c0-3212-d73a-92da-9e6dd85c6ebeProduct name220180118
edcfa1cf-915f-1a4c-d0aa-508cc66e70d9Product name220170816
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
57850177-5927-151f-e1fa-7e2ca47f81e5Product name120140508
8ee71591-1d8f-e24e-242b-bfef131e3168Product name120140508
bff5cf99-0f45-fa15-2a76-b160c3c4cc3cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-301-002019-11-13C16284748780-197449f38-c920-f6ea-e053-dbdaa90aa703Erythromycin Ophthalmic Ointment USP, 0.5% (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-301-00Erythromycin3.5 g in 1 TUBEOINTMENT3.51
52959-301-00Erythromycin1 in 1 CARTONOINTMENT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-301-00GM - Gram52959-301f24672b2-a46f-428c-9082-3a887f424f1512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ERYTHROMYCINACTIVE INGREDIENT63937KV33DERYTHROMYCIN OINTMENT [H.J. HARKINS COMPANY, INC.]1
ERYTHROMYCINACTIVE MOIETY63937KV33DERYTHROMYCIN OINTMENT [H.J. HARKINS COMPANY, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPERYTHROMYCIN OINTMENT [H.J. HARKINS COMPANY, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UERYTHROMYCIN OINTMENT [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-301ERYTHROMYCIN OINTMENT [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 2 package rows20120217_37fcdb6e-2a9b-464f-9a0e-d3ca323fcb7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSN37fcdb6e-2a9b-464f-9a0e-d3ca323fcb7a1
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCD37fcdb6e-2a9b-464f-9a0e-d3ca323fcb7a1
310149erythromycin 0.5 % Ophthalmic OintmentSY37fcdb6e-2a9b-464f-9a0e-d3ca323fcb7a1
310149erythromycin 5 MG per GM Ophthalmic OintmentSY37fcdb6e-2a9b-464f-9a0e-d3ca323fcb7a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52959-301-00529590301003.5 g in 1 TUBE3.5 gHistorical