FDA.reportPublic FDA data

Erythromycin

Product NDC
72485-670
11-digit product format
724850670
Labeler code
72485
Product ID
72485-670_086299e1-e483-5e65-e063-6394a90a29fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
ARMAS PHARMACEUTICALS INC.
Application
ANDA064030
Marketing category
ANDA
Marketing start
2023-10-18
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
72485-670-31Erythromycin1 g in 1 TUBEOINTMENT12
72485-670-31Erythromycin50 in 1 CARTONOINTMENT502
72485-670-35Erythromycin3.5 g in 1 TUBEOINTMENT3.52
72485-670-35Erythromycin1 in 1 CARTONOINTMENT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-670-31GM - Gram72485-670c540d44e-87a0-457c-8885-ce9d029a354312024-02-14
72485-670-35GM - Gram72485-6708e2aca68-823b-48f0-903c-209026a9ce1412024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-670ERYTHROMYCIN OINTMENT [ARMAS PHARMACEUTICALS INC.]2Current NDC, 4 package rows20231024_07fdeac5-f690-d74b-e063-6394a90a5c5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSN301ee5ad-3b6c-1152-e063-6294a90a54e74
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCD301ee5ad-3b6c-1152-e063-6294a90a54e74
310149erythromycin 0.5 % Ophthalmic OintmentSY301ee5ad-3b6c-1152-e063-6294a90a54e74
310149erythromycin 5 MG per GM Ophthalmic OintmentSY301ee5ad-3b6c-1152-e063-6294a90a54e74
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSN07fdeac5-f690-d74b-e063-6394a90a5c5b2
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCD07fdeac5-f690-d74b-e063-6394a90a5c5b2
310149erythromycin 0.5 % Ophthalmic OintmentSY07fdeac5-f690-d74b-e063-6394a90a5c5b2
310149erythromycin 5 MG per GM Ophthalmic OintmentSY07fdeac5-f690-d74b-e063-6394a90a5c5b2
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSN2cc726c2-3746-6dbf-e063-6294a90a789f1
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSN50c8d6b3-4660-e829-e063-6294a90a919b1
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCD2cc726c2-3746-6dbf-e063-6294a90a789f1
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCD50c8d6b3-4660-e829-e063-6294a90a919b1
310149erythromycin 0.5 % Ophthalmic OintmentSY2cc726c2-3746-6dbf-e063-6294a90a789f1
310149erythromycin 0.5 % Ophthalmic OintmentSY50c8d6b3-4660-e829-e063-6294a90a919b1
310149erythromycin 5 MG per GM Ophthalmic OintmentSY2cc726c2-3746-6dbf-e063-6294a90a789f1
310149erythromycin 5 MG per GM Ophthalmic OintmentSY50c8d6b3-4660-e829-e063-6294a90a919b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72485-670-317248506703150 TUBE in 1 CARTON (72485-670-31) / 1 g in 1 TUBE50 tube2023-10-18NoNoCurrent
72485-670-35724850670351 TUBE in 1 CARTON (72485-670-35) / 3.5 g in 1 TUBE1 tube2023-10-18NoNoCurrent