FDA.reportPublic FDA data

ERYTHROMYCIN

Product NDC
61919-090
11-digit product format
619190090
Labeler code
61919
Product ID
61919-090_4d3a76a9-7324-9988-e063-6394a90a2801
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ERYTHROMYCIN
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Direct Rx
Application
ANDA064067
Marketing category
ANDA
Marketing start
2014-01-01
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
2027-12-31
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
A064067-001ERYTHROMYCINERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1994-07-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A064067-001AT

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 22:54:322026-06A064067-001ERYTHROMYCIN0.5%OINTMENT / OPHTHALMICATRS1994-07-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A064067-001AT1a50c72e98297…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ErythromycinERYTHROMYCINSportpharm LLC790d3e3e-df69-45f7-97d5-da65faa465562026-07-21Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067
ErythromycinERYTHROMYCINCardinal Health 107, LLCba4f06c3-ebce-4896-a5cc-59bb5c2cb4e52026-04-27Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067
ErythromycinERYTHROMYCINPreferred Pharmaceuticals, Inc.ee3d806e-65ce-42e1-b170-7b35bcb7b06a2026-04-10Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067
ERYTHROMYCINERYTHROMYCINDirect Rx9ac4dcd2-8cac-404d-b651-da74062d30ed2026-03-17Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067
ndc (product): 61919-090
ErythromycinERYTHROMYCINREMEDYREPACK INC.c49ad63b-c2fd-4535-bec0-6415c93cf8472026-01-09Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067
ErythromycinERYTHROMYCINA-S Medication Solutions2be16639-b153-407b-b43d-3a2bcf66151e2025-12-03Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067
ErythromycinERYTHROMYCINBausch & Lomb Incorporated061ddd20-94a6-4e3c-ba84-1ebd8529eea62025-04-22Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067
ErythromycinERYTHROMYCINNuCare Pharmaceuticals,Inc.5568ade8-bdc2-1a32-e054-00144ff8d46c2024-08-14Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067
ErythromycinERYTHROMYCINNuCare Pharmaceuticals,Inc.6296e2ed-334c-b9af-e053-2991aa0aae0c2024-06-06Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067
ErythromycinERYTHROMYCINProficient Rx LP5101bf55-cacf-42bf-8dd1-2a29e80ca6f12022-07-01Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067
ErythromycinERYTHROMYCINAsclemed USA, Inc.7810e881-5130-4a94-b2e0-9f63f8a7a5042021-11-30Adverse reactionsExact identifier
application applno (ANDA): 064067
application number: ANDA064067

Additional Listing Data#

Finished product
Yes
Brand name base
ERYTHROMYCIN
Listing expiration
2027-12-31

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
9ac4dcd2-8cac-404d-b651-da74062d30edAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-090-352023-01-30C16284748780-1f386c64a-16a7-0266-e053-dadaa90a7c1aERYTHROMYCIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-090-35ERYTHROMYCIN3.5 g in 1 CARTONOINTMENT3.54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-090-35GM - Gram61919-090612cec23-a36b-4c8a-912e-376e2e7a144d12014-11-05

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-090ERYTHROMYCIN OINTMENT [DIRECT RX]3Current NDC, Legacy NDC, 1 package rows20200121_9ac4dcd2-8cac-404d-b651-da74062d30ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310149erythromycin 0.5 % (5 MG/GM) Ophthalmic OintmentPSN9ac4dcd2-8cac-404d-b651-da74062d30ed4
310149erythromycin 0.005 MG/MG Ophthalmic OintmentSCD9ac4dcd2-8cac-404d-b651-da74062d30ed4
310149erythromycin 0.5 % Ophthalmic OintmentSY9ac4dcd2-8cac-404d-b651-da74062d30ed4
310149erythromycin 5 MG per GM Ophthalmic OintmentSY9ac4dcd2-8cac-404d-b651-da74062d30ed4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-090-35619190090353.5 g in 1 CARTON (61919-090-35) 3.5 g2015-01-010000-00-00NoNoCurrent