Home NDC 55289-112 Erythrocin Stearate
Product NDC 55289-112
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 2 · 120 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 55289-112-04 55289011204 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-112-04) 2011-10-03 0000-00-00 No No Current 55289-112-10 55289011210 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-112-10) 2011-10-03 0000-00-00 No No Current 55289-112-15 55289011215 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-112-15) 2011-10-03 0000-00-00 No No Current 55289-112-20 55289011220 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-112-20) 2011-10-03 0000-00-00 No No Current 55289-112-28 55289011228 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-112-28) 2011-10-03 0000-00-00 No No Current 55289-112-40 55289011240 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-112-40) 2011-10-03 0000-00-00 No No Current 55289-112-56 55289011256 56 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-112-56) 2011-10-03 0000-00-00 No No Current 55289-112-98 55289011298 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-112-98) 2011-10-03 0000-00-00 No No Current