FDA.reportPublic FDA data

erythromycin

Product NDC
0574-4024
11-digit product format
005744024
Labeler code
0574
Product ID
0574-4024_e5de2c54-b0ab-4466-8102-74d7da5ac337
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
erythromycin
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Padagis US LLC
Application
ANDA062447
Marketing category
ANDA
Marketing start
2014-05-08
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
No
Listing certified through
2022-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-4024-35GM - Gram0574-40249a87c916-2490-4c08-8964-471e41c5f45112014-07-02
0574-4024-39GM - Gram0574-40244cb5a47a-89ff-45e7-8c36-36df8f52f67512014-11-05
0574-4024-50GM - Gram0574-40240c233232-0d3a-433e-b69a-ab381af03e9e12014-07-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0574-4024ERYTHROMYCIN OINTMENT [PADAGIS US LLC]4Legacy NDC20241103_87b45f99-a4d1-47e0-bbb6-50ca19c10010.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSN1df12239-6957-4b2c-9e65-e2154eafddd015
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCD1df12239-6957-4b2c-9e65-e2154eafddd015
310149erythromycin 0.5 % Ophthalmic OintmentSY1df12239-6957-4b2c-9e65-e2154eafddd015
310149erythromycin 5 MG per GM Ophthalmic OintmentSY1df12239-6957-4b2c-9e65-e2154eafddd015
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSN84119a8f-78d1-2882-e053-2a91aa0a6faa3
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCD84119a8f-78d1-2882-e053-2a91aa0a6faa3
310149erythromycin 0.5 % Ophthalmic OintmentSY84119a8f-78d1-2882-e053-2a91aa0a6faa3
310149erythromycin 5 MG per GM Ophthalmic OintmentSY84119a8f-78d1-2882-e053-2a91aa0a6faa3
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSN946c6eff-715a-2ca2-e053-2a95a90a19041
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSN1f1a4d57-8f3e-e9d6-e063-6294a90ab55c1
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSN6186510d-62ca-4083-9895-8d028d71b5101
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCD946c6eff-715a-2ca2-e053-2a95a90a19041
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCD6186510d-62ca-4083-9895-8d028d71b5101
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCD1f1a4d57-8f3e-e9d6-e063-6294a90ab55c1
310149erythromycin 0.5 % Ophthalmic OintmentSY6186510d-62ca-4083-9895-8d028d71b5101
310149erythromycin 0.5 % Ophthalmic OintmentSY1f1a4d57-8f3e-e9d6-e063-6294a90ab55c1
310149erythromycin 0.5 % Ophthalmic OintmentSY946c6eff-715a-2ca2-e053-2a95a90a19041
310149erythromycin 5 MG per GM Ophthalmic OintmentSY6186510d-62ca-4083-9895-8d028d71b5101
310149erythromycin 5 MG per GM Ophthalmic OintmentSY946c6eff-715a-2ca2-e053-2a95a90a19041
310149erythromycin 5 MG per GM Ophthalmic OintmentSY1f1a4d57-8f3e-e9d6-e063-6294a90ab55c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-4024-35005744024351 TUBE in 1 CARTON (0574-4024-35) > 3.5 g in 1 TUBE1 tube2014-05-080000-00-00NoNoCurrent
0574-4024-390057440243924 TUBE in 1 CARTON (0574-4024-39) > 3.5 g in 1 TUBE24 tube2014-05-080000-00-00NoNoCurrent
0574-4024-500057440245050 TUBE in 1 CARTON (0574-4024-50) > 1 g in 1 TUBE50 tube2014-05-080000-00-00NoNoCurrent