Home NDC 55289-112-01 Erythrocin Stearate
Product NDC 55289-112
Requested package NDC 55289-112-01
11-digit product format 552890112
Labeler code 55289
Product ID 55289-112_e6e9f31e-5a16-4ccf-e053-2a95a90a5adb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ERYTHROMYCIN STEARATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA060359
Marketing category ANDA
Marketing start 2011-08-01
Marketing end 0000-00-00
Substance ERYTHROMYCIN STEARATE
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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A060359-001 ERYTHROCIN STEARATE ERYTHROMYCIN STEARATE EQ 250MG BASE TABLET / ORAL Approved before 1982 A060359-002 ERYTHROCIN STEARATE ERYTHROMYCIN STEARATE EQ 125MG BASE TABLET / ORAL Approved before 1982 A060359-003 ERYTHROCIN STEARATE ERYTHROMYCIN STEARATE EQ 500MG BASE TABLET / ORAL Approved before 1982
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 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 A060359-001 ERYTHROCIN STEARATE EQ 250MG BASE TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A060359-002 ERYTHROCIN STEARATE EQ 125MG BASE TABLET / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A060359-003 ERYTHROCIN STEARATE EQ 500MG BASE TABLET / ORAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A060359-001 ERYTHROCIN STEARATE EQ 250MG BASE TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A060359-002 ERYTHROCIN STEARATE EQ 125MG BASE TABLET / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A060359-003 ERYTHROCIN STEARATE EQ 500MG BASE TABLET / ORAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A060359-001 ERYTHROCIN STEARATE EQ 250MG BASE TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A060359-002 ERYTHROCIN STEARATE EQ 125MG BASE TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A060359-003 ERYTHROCIN STEARATE EQ 500MG BASE TABLET / ORAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A060359-001 ERYTHROCIN STEARATE EQ 250MG BASE TABLET / ORAL RS, Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A060359-002 ERYTHROCIN STEARATE EQ 125MG BASE TABLET / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A060359-003 ERYTHROCIN STEARATE EQ 500MG BASE TABLET / ORAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A060359-001 ERYTHROCIN STEARATE EQ 250MG BASE TABLET / ORAL RS, Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A060359-002 ERYTHROCIN STEARATE EQ 125MG BASE TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A060359-003 ERYTHROCIN STEARATE EQ 500MG BASE TABLET / ORAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A060359-001 ERYTHROCIN STEARATE EQ 250MG BASE TABLET / ORAL RS, Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A060359-002 ERYTHROCIN STEARATE EQ 125MG BASE TABLET / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A060359-003 ERYTHROCIN STEARATE EQ 500MG BASE TABLET / ORAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A060359-001 ERYTHROCIN STEARATE EQ 250MG BASE TABLET / ORAL RS, Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A060359-002 ERYTHROCIN STEARATE EQ 125MG BASE TABLET / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A060359-003 ERYTHROCIN STEARATE EQ 500MG BASE TABLET / ORAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A060359-001 ERYTHROCIN STEARATE EQ 250MG BASE TABLET / ORAL RS, Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A060359-002 ERYTHROCIN STEARATE EQ 125MG BASE TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A060359-003 ERYTHROCIN STEARATE EQ 500MG BASE TABLET / ORAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A060359-001 ERYTHROCIN STEARATE EQ 250MG BASE TABLET / ORAL RS, Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A060359-002 ERYTHROCIN STEARATE EQ 125MG BASE TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A060359-003 ERYTHROCIN STEARATE EQ 500MG BASE TABLET / ORAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A060359-001 ERYTHROCIN STEARATE EQ 250MG BASE TABLET / ORAL RS, Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A060359-002 ERYTHROCIN STEARATE EQ 125MG BASE TABLET / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A060359-003 ERYTHROCIN STEARATE EQ 500MG BASE TABLET / ORAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A060359-001 ERYTHROCIN STEARATE EQ 250MG BASE TABLET / ORAL RS, Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A060359-002 ERYTHROCIN STEARATE EQ 125MG BASE TABLET / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A060359-003 ERYTHROCIN STEARATE EQ 500MG BASE TABLET / ORAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A060359-001 ERYTHROCIN STEARATE EQ 250MG BASE TABLET / ORAL RS, Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A060359-002 ERYTHROCIN STEARATE EQ 125MG BASE TABLET / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A060359-003 ERYTHROCIN STEARATE EQ 500MG BASE TABLET / ORAL Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A060359-001 ERYTHROCIN STEARATE EQ 250MG BASE TABLET / ORAL RS, Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A060359-002 ERYTHROCIN STEARATE EQ 125MG BASE TABLET / ORAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A060359-003 ERYTHROCIN STEARATE EQ 500MG BASE TABLET / ORAL Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A060359-001 ERYTHROCIN STEARATE EQ 250MG BASE TABLET / ORAL RS, Approved before 1982 8072bd15b7f6…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ERYTHROMYCIN STEARATE ACTIVE INGREDIENT LXW024X05M ERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 ERYTHROMYCIN ACTIVE MOIETY 63937KV33D ERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 carboxymethylcellulose sodium INACTIVE INGREDIENT K679OBS311 ERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 D&C Red No. 7 INACTIVE INGREDIENT ECW0LZ41X8 ERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 polacrilin potassium INACTIVE INGREDIENT 0BZ5A00FQU ERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A ERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 povidone INACTIVE INGREDIENT FZ989GH94E ERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 powdered cellulose INACTIVE INGREDIENT SMD1X3XO9M ERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 ERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR ERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 sorbic acid INACTIVE INGREDIENT X045WJ989B ERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 sorbitan monooleate INACTIVE INGREDIENT 06XEA2VD56 ERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 starch, corn INACTIVE INGREDIENT O8232NY3SJ ERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ERYTHROCIN STEARATE (ERYTHROMYCIN STEARATE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55289-112-01 55289011201 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-112-01) 2011-10-03 0000-00-00 No No Current