ERY-TAB

Product NDC
55289-525
11-digit product format
552890525
Labeler code
55289
Product ID
55289-525_e6ecbd49-1d07-06a9-e053-2995a90a8eb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Erythromycin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA062298
Marketing category
ANDA
Marketing start
2011-04-18
Marketing end
0000-00-00
Substance
ERYTHROMYCIN
Active strength
333 mg/1
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55289-525DDiscontinued by firm2026-08-03
excluded packagepackage55289-52555289-525-21DDiscontinued by firm2026-08-03
excluded packagepackage55289-52555289-525-30DDiscontinued by firm2026-08-03
excluded packagepackage55289-52555289-525-40DDiscontinued by firm2026-08-03
excluded packagepackage55289-52555289-525-42DDiscontinued by firm2026-08-03
excluded packagepackage55289-52555289-525-63DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage55289-525-21
excluded packagepackage55289-525-42
excluded packagepackage55289-525-63
excluded packagepackage55289-525-40
excluded packagepackage55289-525-30

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
A062298-001ERY-TABERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALABApproved before 1982
A062298-002ERY-TABERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALABRS, Approved before 1982
A062298-003ERY-TABERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB1982-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062298-001AB
A062298-002AB
A062298-003AB

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 UTC2026-02A062298-001ERY-TAB250MGTABLET, DELAYED RELEASE / ORALABApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062298-002ERY-TAB500MGTABLET, DELAYED RELEASE / ORALABRS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062298-003ERY-TAB333MGTABLET, DELAYED RELEASE / ORALAB1982-03-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062298-001ERY-TAB250MGTABLET, DELAYED RELEASE / ORALABApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062298-002ERY-TAB500MGTABLET, DELAYED RELEASE / ORALABRS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062298-003ERY-TAB333MGTABLET, DELAYED RELEASE / ORALAB1982-03-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A062298-001ERY-TAB250MGTABLET, DELAYED RELEASE / ORALABApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062298-002ERY-TAB500MGTABLET, DELAYED RELEASE / ORALABRS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062298-003ERY-TAB333MGTABLET, DELAYED RELEASE / ORALAB1982-03-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062298-001ERY-TAB250MGTABLET, DELAYED RELEASE / ORALABApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062298-002ERY-TAB500MGTABLET, DELAYED RELEASE / ORALABRS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062298-003ERY-TAB333MGTABLET, DELAYED RELEASE / ORALAB1982-03-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062298-001ERY-TAB250MGTABLET, DELAYED RELEASE / ORALABApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062298-002ERY-TAB500MGTABLET, DELAYED RELEASE / ORALABRS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062298-003ERY-TAB333MGTABLET, DELAYED RELEASE / ORALAB1982-03-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062298-001ERY-TAB250MGTABLET, DELAYED RELEASE / ORALABApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062298-002ERY-TAB500MGTABLET, DELAYED RELEASE / ORALABRS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062298-003ERY-TAB333MGTABLET, DELAYED RELEASE / ORALAB1982-03-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062298-001ERY-TAB250MGTABLET, DELAYED RELEASE / ORALABApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062298-002ERY-TAB500MGTABLET, DELAYED RELEASE / ORALABRS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062298-003ERY-TAB333MGTABLET, DELAYED RELEASE / ORALAB1982-03-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062298-001ERY-TAB250MGTABLET, DELAYED RELEASE / ORALABApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062298-002ERY-TAB500MGTABLET, DELAYED RELEASE / ORALABRS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062298-003ERY-TAB333MGTABLET, DELAYED RELEASE / ORALAB1982-03-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062298-001ERY-TAB250MGTABLET, DELAYED RELEASE / ORALABApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062298-002ERY-TAB500MGTABLET, DELAYED RELEASE / ORALABRS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062298-003ERY-TAB333MGTABLET, DELAYED RELEASE / ORALAB1982-03-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062298-001ERY-TAB250MGTABLET, DELAYED RELEASE / ORALABApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A062298-002ERY-TAB500MGTABLET, DELAYED RELEASE / ORALABRS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A062298-003ERY-TAB333MGTABLET, DELAYED RELEASE / ORALAB1982-03-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062298-001ERY-TAB250MGTABLET, DELAYED RELEASE / ORALABApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062298-002ERY-TAB500MGTABLET, DELAYED RELEASE / ORALABRS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062298-003ERY-TAB333MGTABLET, DELAYED RELEASE / ORALAB1982-03-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062298-001ERY-TAB250MGTABLET, DELAYED RELEASE / ORALABApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062298-002ERY-TAB500MGTABLET, DELAYED RELEASE / ORALABRS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062298-003ERY-TAB333MGTABLET, DELAYED RELEASE / ORALAB1982-03-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062298-001ERY-TAB250MGTABLET, DELAYED RELEASE / ORALABApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062298-002ERY-TAB500MGTABLET, DELAYED RELEASE / ORALABRS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062298-003ERY-TAB333MGTABLET, DELAYED RELEASE / ORALAB1982-03-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062298-001ERY-TAB250MGTABLET, DELAYED RELEASE / ORALABApproved 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 UTC2026-02A062298-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062298-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062298-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062298-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062298-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062298-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062298-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062298-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062298-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062298-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062298-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062298-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062298-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062298-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062298-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062298-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062298-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062298-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062298-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062298-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062298-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062298-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062298-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062298-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062298-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062298-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062298-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062298-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062298-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062298-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062298-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062298-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062298-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062298-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062298-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062298-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062298-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062298-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062298-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062298-001AB18072bd15b7f6…

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
57850177-5927-151f-e1fa-7e2ca47f81e5Product name120140508
8ee71591-1d8f-e24e-242b-bfef131e3168Product name120140508
bff5cf99-0f45-fa15-2a76-b160c3c4cc3cProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-525-21EA - Each55289-5256e9cfc22-ceda-453e-b8f8-696dff71f28212012-07-24
55289-525-30EA - Each55289-525597a6ce8-723e-4166-b31b-dacae9d1acdd12012-07-24
55289-525-40EA - Each55289-525f313eb9d-1b01-46c0-92ca-d55fc5502b8312012-07-24
55289-525-42EA - Each55289-5253c1e9c97-0a2b-4fbc-bedd-43fd8974582212012-07-24
55289-525-63EA - Each55289-525453696fe-c4b6-4d86-a9fc-472b75012e3812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ERYTHROMYCINACTIVE INGREDIENT63937KV33DERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]3
ERYTHROMYCINACTIVE MOIETY63937KV33DERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]3
DIACETYLATED MONOGLYCERIDESINACTIVE INGREDIENT5Z17386USFERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]3
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)INACTIVE INGREDIENT87Y6436BKRERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]3
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-525ERY-TAB (ERYTHROMYCIN) TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]12Legacy NDC20241012_216a7517-bf53-48d1-9613-78c9536c4ebf.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ErythromycinERYTHROMYCINWilshire Pharmaceuticalse9b5abbb-2952-44ce-8cbb-415d9be23df42024-12-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062298
application number: ANDA062298
ERY-TABERYTHROMYCINArbor Pharmaceuticals, Inc.fda44eb6-7901-4b80-ba0b-216f6cacf3fd2018-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062298
application number: ANDA062298

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55289-525-215528905252121 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-525-21) 2011-07-010000-00-00NoNoCurrent
55289-525-305528905253030 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-525-30) 2011-07-010000-00-00NoNoCurrent
55289-525-405528905254040 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-525-40) 2011-07-010000-00-00NoNoCurrent
55289-525-425528905254242 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-525-42) 2011-07-010000-00-00NoNoCurrent
55289-525-635528905256363 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-525-63) 2011-07-010000-00-00NoNoCurrent