erythromycin

Product NDC
76420-612
11-digit product format
764200612
Labeler code
76420
Product ID
76420-612_0523a539-bb30-676e-e063-6394a90af39b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
erythromycin
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Asclemed USA, Inc.
Application
ANDA062447
Marketing category
ANDA
Marketing start
2014-05-08
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
erythromycin
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-612-03erythromycin3.5 g in 1 TUBEOINTMENT3.51
76420-612-03erythromycin1 in 1 CARTONOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-612ERYTHROMYCIN OINTMENT [ASCLEMED USA, INC.]1Current NDC, 2 package rows20230913_6186510d-62ca-4083-9895-8d028d71b510.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSN6186510d-62ca-4083-9895-8d028d71b5101
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCD6186510d-62ca-4083-9895-8d028d71b5101
310149erythromycin 0.5 % Ophthalmic OintmentSY6186510d-62ca-4083-9895-8d028d71b5101
310149erythromycin 5 MG per GM Ophthalmic OintmentSY6186510d-62ca-4083-9895-8d028d71b5101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-612-03764200612031 TUBE in 1 CARTON (76420-612-03) / 3.5 g in 1 TUBE1 tube2023-09-12NoNoHistorical