FDA.reportPublic FDA data

ERYTHROMYCIN

Product NDC
61919-090
11-digit product format
619190090
Labeler code
61919
Product ID
61919-090_4d3a76a9-7324-9988-e063-6394a90a2801
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ERYTHROMYCIN
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Direct Rx
Application
ANDA064067
Marketing category
ANDA
Marketing start
2014-01-01
Substance
ERYTHROMYCIN
Active strength
5 mg/g
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERYTHROMYCIN5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii63937KV33D
Rxcui310149

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
61919-090-352023-01-30C16284748780-1f386c64a-16a7-0266-e053-dadaa90a7c1aERYTHROMYCIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-090-35ERYTHROMYCIN3.5 g in 1 CARTONOINTMENT3.54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-090-35GM - Gram61919-090612cec23-a36b-4c8a-912e-376e2e7a144d12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ERYTHROMYCINACTIVE INGREDIENT63937KV33DERYTHROMYCIN OINTMENT [DIRECT RX]1
ERYTHROMYCINACTIVE MOIETY63937KV33DERYTHROMYCIN OINTMENT [DIRECT RX]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPERYTHROMYCIN OINTMENT [DIRECT RX]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UERYTHROMYCIN OINTMENT [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-090ERYTHROMYCIN OINTMENT [DIRECT RX]3Current NDC, Legacy NDC, 1 package rows20200121_9ac4dcd2-8cac-404d-b651-da74062d30ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSN9ac4dcd2-8cac-404d-b651-da74062d30ed4
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCD9ac4dcd2-8cac-404d-b651-da74062d30ed4
310149erythromycin 0.5 % Ophthalmic OintmentSY9ac4dcd2-8cac-404d-b651-da74062d30ed4
310149erythromycin 5 MG per GM Ophthalmic OintmentSY9ac4dcd2-8cac-404d-b651-da74062d30ed4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-090-35619190090353.5 g in 1 CARTON (61919-090-35) 3.5 g2015-01-010000-00-00NoNoCurrent