FDA.reportPublic FDA data

Erythromycin

Product NDC
55154-7850
11-digit product format
551547850
Labeler code
55154
Product ID
55154-7850_9d665cf2-acb7-468c-9e45-09914584c4fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Cardinal Health 107, LLC
Application
ANDA064067
Marketing category
ANDA
Marketing start
1994-07-29
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
55154-7850-02023-09-15C16284748780-10191ceaa-6f2d-198a-e063-dbdaa90aec3eErythromycin Ophthalmic Ointment USP 0.5% (Sterile) Rx only
55154-7850-02023-07-28C16284748780-10191ceaa-6f2d-198a-e063-dbdaa90aec3eErythromycin Ophthalmic Ointment USP 0.5% (Sterile) Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-7850-0Erythromycin1 g in 1 TUBEOINTMENT19
55154-7850-0Erythromycin10 in 1 BAGOINTMENT109

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-7850ERYTHROMYCIN OINTMENT [CARDINAL HEALTH 107, LLC]7Current NDC, Legacy NDC, 2 package rows20240501_ba4f06c3-ebce-4896-a5cc-59bb5c2cb4e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSNba4f06c3-ebce-4896-a5cc-59bb5c2cb4e59
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCDba4f06c3-ebce-4896-a5cc-59bb5c2cb4e59
310149erythromycin 0.5 % Ophthalmic OintmentSYba4f06c3-ebce-4896-a5cc-59bb5c2cb4e59
310149erythromycin 5 MG per GM Ophthalmic OintmentSYba4f06c3-ebce-4896-a5cc-59bb5c2cb4e59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-7850-05515478500010 TUBE in 1 BAG (55154-7850-0) / 1 g in 1 TUBE10 tube1994-07-290000-00-00NoNoCurrent