FDA.reportPublic FDA data

Erythromycin

Product NDC
67296-2128
11-digit product format
672962128
Labeler code
67296
Product ID
67296-2128_4698d3a7-6b27-7aee-e063-6394a90a65df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Redpharm Drug
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A064030-001ERYTHROMYCINERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A064030-001AT

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A064030-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICAT1996-07-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A064030-001AT1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ErythromycinERYTHROMYCINNuCare Pharmaceuticals,Inc.50c8d6b3-4660-e829-e063-6294a90a919b2026-05-01Adverse reactionsExact identifier
application applno (ANDA): 064030
application number: ANDA064030
ErythromycinERYTHROMYCINSentiss Pharmaceuticals LLC4da0e351-383f-55da-e063-6394a90a8eba2026-03-31Adverse reactionsExact identifier
application applno (ANDA): 064030
application number: ANDA064030
ErythromycinERYTHROMYCINRedpharm Drug301ee5ad-3b6c-1152-e063-6294a90a54e72025-12-23Adverse reactionsExact identifier
application applno (ANDA): 064030
application number: ANDA064030
ndc (product): 67296-2128
ErythromycinERYTHROMYCINST. MARY'S MEDICAL PARK PHARMACY2cc726c2-3746-6dbf-e063-6294a90a789f2025-01-28Adverse reactionsExact identifier
application applno (ANDA): 064030
application number: ANDA064030
ErythromycinERYTHROMYCINARMAS PHARMACEUTICALS INC.07fdeac5-f690-d74b-e063-6394a90a5c5b2023-10-23Adverse reactionsExact identifier
application applno (ANDA): 064030
application number: ANDA064030
ErythromycinERYTHROMYCINProficient Rx LP62896bec-669e-4f20-a1e4-4f99afd35d322022-04-01Adverse reactionsExact identifier
application applno (ANDA): 064030
application number: ANDA064030
ErythromycinERYTHROMYCINAsclemed USA, Inc.bccdb8f3-b5f5-4f07-8ddb-8811d5c1b73c2022-03-07Adverse reactionsExact identifier
application applno (ANDA): 064030
application number: ANDA064030

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
301ee5ad-3b6c-1152-e063-6294a90a54e7Available 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
67296-2128-3Erythromycin3.5 g in 1 TUBEOINTMENT3.54
67296-2128-3Erythromycin1 in 1 CARTONOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-2128ERYTHROMYCIN OINTMENT [REDPHARM DRUG]1Current NDC, 2 package rows20250313_301ee5ad-3b6c-1152-e063-6294a90a54e7.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2128-3672962128031 TUBE in 1 CARTON (67296-2128-3) / 3.5 g in 1 TUBE1 tube2023-10-18NoNoCurrent