E.E.S

Product NDC
80005-153
Requested package NDC
80005-153-34
11-digit product format
800050153
Labeler code
80005
Product ID
80005-153_ad0b7a24-6fae-4dfd-a308-4fd9c543d7e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin Ethylsuccinate
Dosage form
GRANULE, FOR SUSPENSION
Route
ORAL
Labeler
Carnegie Pharmaceuticals LLC
Application
NDA050207
Marketing category
NDA
Marketing start
2025-01-15
Substance
ERYTHROMYCIN ETHYLSUCCINATE
Active strength
200 mg/5mL
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage80005-15380005-153-34IInactivated by FDA2026-08-03

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050207-001E.E.S.ERYTHROMYCIN ETHYLSUCCINATEEQ 200MG BASE/5MLGRANULE / ORALABRLD, Approved before 1982
N050207-002ERYPEDERYTHROMYCIN ETHYLSUCCINATEEQ 400MG BASE/5MLGRANULE / ORALABRLD, RS, Approved before 1982
N050207-003ERYPEDERYTHROMYCIN ETHYLSUCCINATEEQ 200MG BASE/5MLGRANULE / ORALABRLD1987-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N050207-001AB
N050207-002AB
N050207-003AB

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050207-001E.E.S.EQ 200MG BASE/5MLGRANULE / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050207-002ERYPEDEQ 400MG BASE/5MLGRANULE / ORALABRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050207-003ERYPEDEQ 200MG BASE/5MLGRANULE / ORALABRLD1987-03-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050207-001E.E.S.EQ 200MG BASE/5MLGRANULE / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050207-002ERYPEDEQ 400MG BASE/5MLGRANULE / ORALABRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050207-003ERYPEDEQ 200MG BASE/5MLGRANULE / ORALABRLD1987-03-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N050207-001E.E.S.EQ 200MG BASE/5MLGRANULE / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050207-002ERYPEDEQ 400MG BASE/5MLGRANULE / ORALABRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050207-003ERYPEDEQ 200MG BASE/5MLGRANULE / ORALABRLD1987-03-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050207-001E.E.S.EQ 200MG BASE/5MLGRANULE / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050207-002ERYPEDEQ 400MG BASE/5MLGRANULE / ORALABRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050207-003ERYPEDEQ 200MG BASE/5MLGRANULE / ORALABRLD1987-03-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050207-001E.E.S.EQ 200MG BASE/5MLGRANULE / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050207-002ERYPEDEQ 400MG BASE/5MLGRANULE / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050207-003ERYPEDEQ 200MG BASE/5MLGRANULE / ORALABRLD1987-03-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050207-001E.E.S.EQ 200MG BASE/5MLGRANULE / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050207-002ERYPEDEQ 400MG BASE/5MLGRANULE / ORALABRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050207-003ERYPEDEQ 200MG BASE/5MLGRANULE / ORALABRLD1987-03-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050207-001E.E.S.EQ 200MG BASE/5MLGRANULE / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050207-002ERYPEDEQ 400MG BASE/5MLGRANULE / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050207-003ERYPEDEQ 200MG BASE/5MLGRANULE / ORALABRLD1987-03-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050207-001E.E.S.EQ 200MG BASE/5MLGRANULE / ORALABRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050207-002ERYPEDEQ 400MG BASE/5MLGRANULE / ORALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050207-003ERYPEDEQ 200MG BASE/5MLGRANULE / ORALABRLD1987-03-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050207-001E.E.S.EQ 200MG BASE/5MLGRANULE / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050207-002ERYPEDEQ 400MG BASE/5MLGRANULE / ORALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050207-003ERYPEDEQ 200MG BASE/5MLGRANULE / ORALABRLD1987-03-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050207-001E.E.S.EQ 200MG BASE/5MLGRANULE / ORALABRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N050207-002ERYPEDEQ 400MG BASE/5MLGRANULE / ORALABRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N050207-003ERYPEDEQ 200MG BASE/5MLGRANULE / ORALABRLD1987-03-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050207-001E.E.S.EQ 200MG BASE/5MLGRANULE / ORALABRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050207-002ERYPEDEQ 400MG BASE/5MLGRANULE / ORALABRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050207-003ERYPEDEQ 200MG BASE/5MLGRANULE / ORALABRLD1987-03-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050207-001E.E.S.EQ 200MG BASE/5MLGRANULE / ORALABRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050207-002ERYPEDEQ 400MG BASE/5MLGRANULE / ORALABRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050207-003ERYPEDEQ 200MG BASE/5MLGRANULE / ORALABRLD1987-03-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050207-001E.E.S.EQ 200MG BASE/5MLGRANULE / ORALABRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050207-002ERYPEDEQ 400MG BASE/5MLGRANULE / ORALABRLD, RS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050207-003ERYPEDEQ 200MG BASE/5MLGRANULE / ORALABRLD1987-03-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050207-001E.E.S.EQ 200MG BASE/5MLGRANULE / ORALABRLD, Approved before 19828072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N050207-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050207-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050207-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050207-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050207-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050207-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050207-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050207-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050207-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050207-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050207-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050207-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050207-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050207-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050207-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050207-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050207-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050207-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050207-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050207-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050207-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050207-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050207-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050207-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050207-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050207-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050207-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050207-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N050207-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N050207-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050207-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050207-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050207-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050207-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050207-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050207-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050207-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050207-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050207-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050207-001AB18072bd15b7f6…

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
80005-153-34E.E.S200 mL in 1 BOTTLEGRANULE, FOR SUSPENSION2002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80005-153-34ML - Milliliter80005-1537e51a994-90db-4989-ac32-460a7e6ee2e212025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80005-153E.E.S 400 (ERYTHROMYCIN ETHYLSUCCINATE) TABLET E.E.S (ERYTHROMYCIN ETHYLSUCCINATE) GRANULE, FOR SUSPENSION [CARNEGIE PHARMACEUTICALS LLC]2Current NDC, 1 package rows20250226_91479d92-3bf3-4eb3-81bd-8ce4956d4347.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
E.E.S 400ERYTHROMYCIN ETHYLSUCCINATEAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)b455bbdb-a3f1-470f-aa5f-ed83ac2e228d2023-12-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 050207
application number: NDA050207
Ery-PedERYTHROMYCIN ETHYLSUCCINATEAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)04775721-ab87-4b66-808c-d67a210323852023-12-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 050207
application number: NDA050207
ERYTHROMYCIN ETHYLSUCCINATEERYTHROMYCIN ETHYLSUCCINATEWilshire Pharmaceuticals86d6353c-2b58-4219-b31d-fb5b977890942020-09-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 050207
application number: NDA050207
Erythromycin EthylsuccinateERYTHROMYCIN ETHYLSUCCINATEWilshire Pharmaceuticals Inc.f4a3fffd-ce02-450f-bbcc-d425374e3e322019-01-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 050207
application number: NDA050207

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
863603E.E.S. 200 MG in 5 mL Oral SuspensionPSN91479d92-3bf3-4eb3-81bd-8ce4956d43472
863606E.E.S. 400 MG Oral TabletPSN91479d92-3bf3-4eb3-81bd-8ce4956d43472
686400erythromycin ethylsuccinate 200 MG in 5 mL Oral SuspensionPSN91479d92-3bf3-4eb3-81bd-8ce4956d43472
686405erythromycin ethylsuccinate 400 MG Oral TabletPSN91479d92-3bf3-4eb3-81bd-8ce4956d43472
863603erythromycin ethylsuccinate 40 MG/ML Oral Suspension [E.E.S.]SBD91479d92-3bf3-4eb3-81bd-8ce4956d43472
863606erythromycin ethylsuccinate 400 MG Oral Tablet [E.E.S.]SBD91479d92-3bf3-4eb3-81bd-8ce4956d43472
686400erythromycin ethylsuccinate 40 MG/ML Oral SuspensionSCD91479d92-3bf3-4eb3-81bd-8ce4956d43472
686405erythromycin ethylsuccinate 400 MG Oral TabletSCD91479d92-3bf3-4eb3-81bd-8ce4956d43472
863603E.E.S. 200 MG per 5 ML Oral SuspensionSY91479d92-3bf3-4eb3-81bd-8ce4956d43472
863603E.E.S. 200 Oral SuspensionSY91479d92-3bf3-4eb3-81bd-8ce4956d43472
863603E.E.S. 40 MG/ML Oral SuspensionSY91479d92-3bf3-4eb3-81bd-8ce4956d43472
863606E.E.S. 400 MG Oral TabletSY91479d92-3bf3-4eb3-81bd-8ce4956d43472
686400EES 40 MG/ML Oral SuspensionSY91479d92-3bf3-4eb3-81bd-8ce4956d43472
863603EES 40 MG/ML Oral Suspension [E.E.S.]SY91479d92-3bf3-4eb3-81bd-8ce4956d43472
686405EES 400 MG Oral TabletSY91479d92-3bf3-4eb3-81bd-8ce4956d43472
863606EES 400 MG Oral Tablet [E.E.S.]SY91479d92-3bf3-4eb3-81bd-8ce4956d43472
686400erythromycin ethylsuccinate 200 MG per 5 ML Oral SuspensionSY91479d92-3bf3-4eb3-81bd-8ce4956d43472

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80005-153-3480005015334200 mL in 1 BOTTLE (80005-153-34) 200 ml2025-01-15NoNoHistorical