FDA.reportPublic FDA data

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 1.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A211975-001ERYTHROMYCIN250MGTABLET, DELAYED RELEASE / ORALAB2021-07-26a50c72e98297…
2026-08-01 22:54:322026-06A211975-002ERYTHROMYCIN500MGTABLET, DELAYED RELEASE / ORALAB2021-07-26a50c72e98297…
2026-08-01 22:54:322026-06A211975-003ERYTHROMYCIN333MGTABLET, DELAYED RELEASE / ORALAB2024-08-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211975-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A211975-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A211975-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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