FDA.reportPublic FDA data

Erythromycin

Product NDC
48102-057
11-digit product format
481020057
Labeler code
48102
Product ID
48102-057_3365af10-cb24-4961-8511-1ef46c9eebcc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Fera Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start
2023-09-27
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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
63937KV33DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310149Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
be59bb85-8ef4-4f9e-85e5-c05662ecd1eeAvailable on FDA.report

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
48102-057-11Erythromycin50 in 1 CARTONOINTMENT503
48102-057-11Erythromycin1 g in 1 TUBEOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48102-057ERYTHROMYCIN OINTMENT [FERA PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20240216_be59bb85-8ef4-4f9e-85e5-c05662ecd1ee.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ErythromycinERYTHROMYCINFera Pharmaceuticals, LLCbe59bb85-8ef4-4f9e-85e5-c05662ecd1ee2023-10-26Exact identifier
ndc (product): 48102-057

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSNbe59bb85-8ef4-4f9e-85e5-c05662ecd1ee3
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCDbe59bb85-8ef4-4f9e-85e5-c05662ecd1ee3
310149erythromycin 0.5 % Ophthalmic OintmentSYbe59bb85-8ef4-4f9e-85e5-c05662ecd1ee3
310149erythromycin 5 MG per GM Ophthalmic OintmentSYbe59bb85-8ef4-4f9e-85e5-c05662ecd1ee3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48102-057-114810200571150 TUBE in 1 CARTON (48102-057-11) / 1 g in 1 TUBE50 tube2023-09-27NoNoCurrent