Home NDC 21695-389 ERYTHROMYCIN Base Filmtab
Product NDC 21695-389
11-digit product format 216950389
Labeler code 21695
Product ID 21695-389_e83ebf1a-2719-4f52-a47d-3d5af9e8d6f4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ERYTHROMYCIN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rebel Distributors Corp
Application ANDA061621
Marketing category ANDA
Marketing start 1972-07-11
Marketing end 0000-00-00
Substance ERYTHROMYCIN
Active strength 500 mg/1
Pharmacologic classes Decreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 21695-389-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 21695-389-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 21695-389-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 21695-389-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 21695-389-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 21695-389-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 21695-389-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 21695-389-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 21695-389-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 21695-389-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 21695-389-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 21695-389-30 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 21695-389-30 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 21695-389-30 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 21695-389-30 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 21695-389-30 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 21695-389-30 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 21695-389-30 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 21695-389-30 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 21695-389-30 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 21695-389-30 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 21695-389-30 110d247fa046…a55b01930146…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 21695-389-30 ERYTHROMYCIN Base Filmtab 30 in 1 BOTTLE TABLET, FILM COATED 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ERYTHROMYCIN ACTIVE INGREDIENT 63937KV33D ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 ERYTHROMYCIN ACTIVE MOIETY 63937KV33D ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 D&C RED NO. 30 INACTIVE INGREDIENT 2S42T2808B ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 sorbic acid INACTIVE INGREDIENT X045WJ989B ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 SORBITAN MONOOLEATE INACTIVE INGREDIENT 06XEA2VD56 ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 talc INACTIVE INGREDIENT 7SEV7J4R1U ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21695-389 ERYTHROMYCIN BASE FILMTAB (ERYTHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 Legacy NDC, 1 package rows 20110103_e83ebf1a-2719-4f52-a47d-3d5af9e8d6f4.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 Status 21695-389-30 21695038930 30 in 1 BOTTLE Historical