ERYTHROMYCIN

Product NDC
13668-587
11-digit product format
136680587
Labeler code
13668
Product ID
13668-587_8c400049-2b9b-476d-a993-06aa5d3beba9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ERYTHROMYCIN
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA211975
Marketing category
ANDA
Marketing start
2024-10-21
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A211975-001ERYTHROMYCINERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2021-07-26
A211975-002ERYTHROMYCINERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2021-07-26
A211975-003ERYTHROMYCINERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2024-08-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211975-001AB
A211975-002AB
A211975-003AB

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 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A211975-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2021-07-26caaa826d4ba7…
2026-08-18 06:07:402026-07A211975-002ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2021-07-26caaa826d4ba7…
2026-08-18 06:07:402026-07A211975-003ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2024-08-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211975-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2021-07-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211975-002ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2021-07-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211975-003ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2024-08-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211975-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2021-07-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211975-002ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2021-07-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211975-003ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2024-08-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A211975-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2021-07-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211975-002ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2021-07-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211975-003ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2024-08-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211975-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2021-07-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211975-002ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2021-07-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211975-003ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2024-08-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211975-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2021-07-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211975-002ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2021-07-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211975-003ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2024-08-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211975-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2021-07-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211975-002ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2021-07-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211975-003ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2024-08-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211975-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2021-07-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211975-002ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2021-07-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211975-003ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2024-08-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211975-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2021-07-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211975-002ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2021-07-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211975-003ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2024-08-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211975-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2021-07-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211975-002ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2021-07-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211975-003ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2024-08-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211975-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2021-07-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A211975-002ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2021-07-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A211975-003ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2024-08-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211975-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2021-07-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211975-002ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2021-07-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211975-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2021-07-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211975-002ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2021-07-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211975-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2021-07-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211975-002ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2021-07-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211975-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2021-07-268072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A211975-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211975-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211975-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211975-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211975-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211975-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211975-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211975-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211975-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211975-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211975-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211975-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211975-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211975-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211975-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211975-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211975-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211975-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211975-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211975-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211975-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211975-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211975-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211975-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211975-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211975-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211975-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211975-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211975-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211975-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211975-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211975-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211975-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211975-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211975-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211975-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211975-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211975-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211975-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211975-001AB18072bd15b7f6…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211975-003CGT2025-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A211975-003CGT2025-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211975-003CGT2025-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211975-003CGT2025-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211975-003CGT2025-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211975-003CGT2025-04-222680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211975-003CGT2025-04-22d8e5a09893c0…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211975-001CGT2022-04-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211975-002CGT2022-04-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211975-001CGT2022-04-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211975-002CGT2022-04-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211975-001CGT2022-04-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211975-002CGT2022-04-024b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211975-001CGT2022-04-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211975-002CGT2022-04-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211975-001CGT2022-04-02782e0a99824c…
2021-12-28 21:50 UTC2021-12A211975-002CGT2022-04-02782e0a99824c…
2023-01-26 05:58 UTC2023-01A211975-001CGT2022-04-023bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A211975-002CGT2022-04-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211975-001CGT2022-04-023a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211975-002CGT2022-04-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211975-001CGT2022-04-02f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A211975-002CGT2022-04-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211975-001CGT2022-04-02e64feba35796…
2022-09-29 23:25 UTC2022-09A211975-002CGT2022-04-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211975-001CGT2022-04-02cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211975-002CGT2022-04-02cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
ERYTHROMYCIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERYTHROMYCIN333 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
63937KV33DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310155Internal RxNorm lookup
310157Internal RxNorm lookup
315090Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
66b0d891-8756-43d1-b046-6dba787dd96fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d329c2e1-5ae8-4e64-aea0-77ecea3fa1abProduct name320250717
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
3b331500-3b74-bd2b-fede-d46839f2f4d5Product name620240313
fdae2630-eae0-4769-abfd-8f33d5b771b4Product name320240202
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
8c898317-b543-1e4e-254f-84cec2f3f57eProduct name220191002
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
64ae94c0-3212-d73a-92da-9e6dd85c6ebeProduct name220180118
edcfa1cf-915f-1a4c-d0aa-508cc66e70d9Product name220170816
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
57850177-5927-151f-e1fa-7e2ca47f81e5Product name120140508
8ee71591-1d8f-e24e-242b-bfef131e3168Product name120140508
bff5cf99-0f45-fa15-2a76-b160c3c4cc3cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-587-01ERYTHROMYCIN100 in 1 BOTTLETABLET, DELAYED RELEASE1007
13668-587-05ERYTHROMYCIN500 in 1 BOTTLETABLET, DELAYED RELEASE5007
13668-587-30ERYTHROMYCIN30 in 1 BOTTLETABLET, DELAYED RELEASE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-587-30EA - Each13668-5876d5b5c5d-07aa-4629-b62c-179211cb3a8a12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-587ERYTHROMYCIN TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]7Current NDC, 3 package rows20241022_66b0d891-8756-43d1-b046-6dba787dd96f.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
ERYTHROMYCINERYTHROMYCINGolden State Medical Supply, Inc.0c0560be-fb11-509d-e063-6394a90ab6f72024-11-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211975
application number: ANDA211975
ERYTHROMYCINERYTHROMYCINTorrent Pharmaceuticals Limited66b0d891-8756-43d1-b046-6dba787dd96f2024-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211975
application number: ANDA211975
ndc (product): 13668-587

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310155erythromycin 250 MG Delayed Release Oral TabletPSN66b0d891-8756-43d1-b046-6dba787dd96f7
315090erythromycin 333 MG Delayed Release Oral TabletPSN66b0d891-8756-43d1-b046-6dba787dd96f7
310157erythromycin 500 MG Delayed Release Oral TabletPSN66b0d891-8756-43d1-b046-6dba787dd96f7
310155erythromycin 250 MG Delayed Release Oral TabletSCD66b0d891-8756-43d1-b046-6dba787dd96f7
315090erythromycin 333 MG Delayed Release Oral TabletSCD66b0d891-8756-43d1-b046-6dba787dd96f7
310157erythromycin 500 MG Delayed Release Oral TabletSCD66b0d891-8756-43d1-b046-6dba787dd96f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
13668-587-0113668058701100 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-587-01) 2024-10-21NoNoCurrent
13668-587-0513668058705500 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-587-05) 2024-10-21NoNoCurrent
13668-587-301366805873030 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-587-30) 2024-10-21NoNoCurrent