Home NDC 55289-075 Erythromycin
Product NDC 55289-075
11-digit product format 552890075
Labeler code 55289
Product ID 55289-075_4199686c-7009-b215-e063-6294a90aaa02
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Erythromycin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA061621
Marketing category ANDA
Marketing start 2011-09-06
Substance ERYTHROMYCIN
Active strength 250 mg/1
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A061621-001 ERYTHROMYCIN ERYTHROMYCIN 250MG TABLET / ORAL AB Approved before 1982 A061621-002 ERYTHROMYCIN ERYTHROMYCIN 500MG TABLET / ORAL AB Approved before 1982
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A061621-001 ERYTHROMYCIN 250MG TABLET / ORAL AB Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A061621-002 ERYTHROMYCIN 500MG TABLET / ORAL AB Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061621-001 ERYTHROMYCIN 250MG TABLET / ORAL AB Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A061621-002 ERYTHROMYCIN 500MG TABLET / ORAL AB Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A061621-001 ERYTHROMYCIN 250MG TABLET / ORAL AB Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A061621-002 ERYTHROMYCIN 500MG TABLET / ORAL AB Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061621-001 ERYTHROMYCIN 250MG TABLET / ORAL AB Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A061621-002 ERYTHROMYCIN 500MG TABLET / ORAL AB Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061621-001 ERYTHROMYCIN 250MG TABLET / ORAL AB Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A061621-002 ERYTHROMYCIN 500MG TABLET / ORAL AB Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061621-001 ERYTHROMYCIN 250MG TABLET / ORAL AB Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A061621-002 ERYTHROMYCIN 500MG TABLET / ORAL AB Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A061621-001 ERYTHROMYCIN 250MG TABLET / ORAL AB Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A061621-002 ERYTHROMYCIN 500MG TABLET / ORAL AB Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A061621-001 ERYTHROMYCIN 250MG TABLET / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A061621-002 ERYTHROMYCIN 500MG TABLET / ORAL AB Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A061621-001 ERYTHROMYCIN 250MG TABLET / ORAL AB Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A061621-002 ERYTHROMYCIN 500MG TABLET / ORAL AB Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A061621-001 ERYTHROMYCIN 250MG TABLET / ORAL AB Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A061621-002 ERYTHROMYCIN 500MG TABLET / ORAL AB Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A061621-001 ERYTHROMYCIN 250MG TABLET / ORAL AB Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A061621-002 ERYTHROMYCIN 500MG TABLET / ORAL AB Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A061621-001 ERYTHROMYCIN 250MG TABLET / ORAL AB Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A061621-002 ERYTHROMYCIN 500MG TABLET / ORAL AB Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A061621-001 ERYTHROMYCIN 250MG TABLET / ORAL AB Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A061621-002 ERYTHROMYCIN 500MG TABLET / ORAL AB Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A061621-001 ERYTHROMYCIN 250MG TABLET / ORAL AB Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A061621-002 ERYTHROMYCIN 500MG TABLET / ORAL AB Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A061621-001 ERYTHROMYCIN 250MG TABLET / ORAL AB Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A061621-002 ERYTHROMYCIN 500MG TABLET / ORAL AB RS, Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A061621-001 ERYTHROMYCIN 250MG TABLET / ORAL AB Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A061621-002 ERYTHROMYCIN 500MG TABLET / ORAL AB RS, Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A061621-001 ERYTHROMYCIN 250MG TABLET / ORAL AB Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A061621-002 ERYTHROMYCIN 500MG TABLET / ORAL AB RS, Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A061621-001 ERYTHROMYCIN 250MG TABLET / ORAL AB Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A061621-002 ERYTHROMYCIN 500MG TABLET / ORAL AB RS, Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A061621-001 ERYTHROMYCIN 250MG TABLET / ORAL AB Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A061621-002 ERYTHROMYCIN 500MG TABLET / ORAL AB RS, Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A061621-001 ERYTHROMYCIN 250MG TABLET / ORAL AB Approved before 1982 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A061621-002 ERYTHROMYCIN 500MG TABLET / ORAL AB RS, Approved before 1982 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Erythromycin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ERYTHROMYCIN 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 63937KV33D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 598006 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55289-075-03 Erythromycin 3 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 3 19 55289-075-40 Erythromycin 40 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 40 19 55289-075-56 Erythromycin 56 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 56 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Erythromycin ACTIVE INGREDIENT 63937KV33D ERYTHROMYCIN BASE BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 Erythromycin ACTIVE MOIETY 63937KV33D ERYTHROMYCIN BASE BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 aluminum oxide INACTIVE INGREDIENT LMI26O6933 ERYTHROMYCIN BASE BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U ERYTHROMYCIN BASE BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 ERYTHROMYCIN BASE BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 crospovidone INACTIVE INGREDIENT 68401960MK ERYTHROMYCIN BASE BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 D&C Red No. 30 INACTIVE INGREDIENT 2S42T2808B ERYTHROMYCIN BASE BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 hydroxypropyl cellulose (type H) INACTIVE INGREDIENT RFW2ET671P ERYTHROMYCIN BASE BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO ERYTHROMYCIN BASE BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ERYTHROMYCIN BASE BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A ERYTHROMYCIN BASE BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 povidones INACTIVE INGREDIENT FZ989GH94E ERYTHROMYCIN BASE BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 ERYTHROMYCIN BASE BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 ERYTHROMYCIN BASE BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR ERYTHROMYCIN BASE BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I ERYTHROMYCIN BASE BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 sorbic acid INACTIVE INGREDIENT X045WJ989B ERYTHROMYCIN BASE BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 sorbitan monooleate INACTIVE INGREDIENT 06XEA2VD56 ERYTHROMYCIN BASE BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 talc INACTIVE INGREDIENT 7SEV7J4R1U ERYTHROMYCIN BASE BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ERYTHROMYCIN BASE BASE (ERYTHROMYCIN) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55289-075 ERYTHROMYCIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 Current NDC, Legacy NDC, 3 package rows 20241011_e54d66fa-93bb-4339-a75e-194a2e4488aa.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55289-075-03 55289007503 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-075-03) 2013-12-18 0000-00-00 No No Current 55289-075-40 55289007540 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-075-40) 2013-12-18 0000-00-00 No No Current 55289-075-56 55289007556 56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-075-56) 2013-12-18 0000-00-00 No No Current