Erythromycin

Product NDC
17478-070
11-digit product format
174780070
Labeler code
17478
Product ID
17478-070_6d8d9148-981f-4930-8d60-95ab92ce4e1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Akorn
Application
ANDA064030
Marketing category
ANDA
Marketing start
1996-07-18
Marketing end
0000-00-00
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
2023-12-31
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
17478-070-312024-01-30C16284748780-11030e365-5558-111a-e063-dadaa90a10e2Erythromycin Ophthalmic Ointment USP, 0.5%
17478-070-352024-01-30C16284748780-11030e365-5558-111a-e063-dadaa90a10e2Erythromycin Ophthalmic Ointment USP, 0.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17478-070-31Erythromycin1 g in 1 TUBEOINTMENT19
17478-070-31Erythromycin50 in 1 CARTONOINTMENT509
17478-070-35Erythromycin1 in 1 CARTONOINTMENT19
17478-070-35Erythromycin3.5 g in 1 TUBEOINTMENT3.59

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-070-31GM - Gram17478-070fd4abc07-1c54-4954-b3fd-2d91b9875c2e12012-07-24
17478-070-35GM - Gram17478-0700e89b274-9b8a-41f2-865f-62c815064b6312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ErythromycinACTIVE INGREDIENT63937KV33DERYTHROMYCIN OINTMENT [AKORN, INC.]3
ErythromycinACTIVE MOIETY63937KV33DERYTHROMYCIN OINTMENT [AKORN, INC.]3
mineral oilINACTIVE INGREDIENTT5L8T28FGPERYTHROMYCIN OINTMENT [AKORN, INC.]3
petrolatumINACTIVE INGREDIENT4T6H12BN9UERYTHROMYCIN OINTMENT [AKORN, INC.]3
ERYTHROMYCINACTIVE INGREDIENT63937KV33DERYTHROMYCIN OINTMENT [PROFICIENT RX LP]1
ErythromycinACTIVE INGREDIENT63937KV33DERYTHROMYCIN OINTMENT [DISPENSING SOLUTIONS, INC.]1
ERYTHROMYCINACTIVE MOIETY63937KV33DERYTHROMYCIN OINTMENT [PROFICIENT RX LP]1
ErythromycinACTIVE MOIETY63937KV33DERYTHROMYCIN OINTMENT [DISPENSING SOLUTIONS, INC.]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPERYTHROMYCIN OINTMENT [PROFICIENT RX LP]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPERYTHROMYCIN OINTMENT [DISPENSING SOLUTIONS, INC.]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UERYTHROMYCIN OINTMENT [PROFICIENT RX LP]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UERYTHROMYCIN OINTMENT [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-070ERYTHROMYCIN OINTMENT [AKORN]9Legacy NDC, 4 package rows20220914_a0353c10-48c9-4d2a-8047-56ea68ace956.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSNa0353c10-48c9-4d2a-8047-56ea68ace9569
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCDa0353c10-48c9-4d2a-8047-56ea68ace9569
310149erythromycin 0.5 % Ophthalmic OintmentSYa0353c10-48c9-4d2a-8047-56ea68ace9569
310149erythromycin 5 MG per GM Ophthalmic OintmentSYa0353c10-48c9-4d2a-8047-56ea68ace9569
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSN62896bec-669e-4f20-a1e4-4f99afd35d324
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCD62896bec-669e-4f20-a1e4-4f99afd35d324
310149erythromycin 0.5 % Ophthalmic OintmentSY62896bec-669e-4f20-a1e4-4f99afd35d324
310149erythromycin 5 MG per GM Ophthalmic OintmentSY62896bec-669e-4f20-a1e4-4f99afd35d324
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSNbccdb8f3-b5f5-4f07-8ddb-8811d5c1b73c1
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSNe453b459-9aa7-4873-9b62-340a81aa050b1
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCDbccdb8f3-b5f5-4f07-8ddb-8811d5c1b73c1
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCDe453b459-9aa7-4873-9b62-340a81aa050b1
310149erythromycin 0.5 % Ophthalmic OintmentSYbccdb8f3-b5f5-4f07-8ddb-8811d5c1b73c1
310149erythromycin 0.5 % Ophthalmic OintmentSYe453b459-9aa7-4873-9b62-340a81aa050b1
310149erythromycin 5 MG per GM Ophthalmic OintmentSYbccdb8f3-b5f5-4f07-8ddb-8811d5c1b73c1
310149erythromycin 5 MG per GM Ophthalmic OintmentSYe453b459-9aa7-4873-9b62-340a81aa050b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17478-070-311747800703150 TUBE in 1 CARTON (17478-070-31) > 1 g in 1 TUBE50 tube1996-07-180000-00-00NoNoCurrent
17478-070-35174780070351 TUBE in 1 CARTON (17478-070-35) > 3.5 g in 1 TUBE1 tube1996-07-180000-00-00NoNoCurrent