FDA.reportPublic FDA data

CLARITHROMYCIN

Product NDC
62135-616
11-digit product format
621350616
Labeler code
62135
Product ID
62135-616_f08573c8-02d4-3717-e053-2a95a90a2dda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chartwell RX, LLC.
Application
ANDA065384
Marketing category
ANDA
Marketing start
2007-08-20
Substance
CLARITHROMYCIN
Active strength
250 mg/1
Pharmacologic classes
Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065384-001CLARITHROMYCINCLARITHROMYCIN250MGTABLET / ORALAB2007-08-20
A065384-002CLARITHROMYCINCLARITHROMYCIN500MGTABLET / ORALAB2007-08-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A065384-001AB
A065384-002AB

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 22:54:322026-06A065384-001CLARITHROMYCIN250MGTABLET / ORALAB2007-08-20a50c72e98297…
2026-08-01 22:54:322026-06A065384-002CLARITHROMYCIN500MGTABLET / ORALAB2007-08-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065384-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A065384-002AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLARITHROMYCINCLARITHROMYCINChartwell RX, LLC.99d2fd6b-39ca-42f9-ad06-30e7fbc22c472022-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065384
application number: ANDA065384
ndc (product): 62135-616

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLARITHROMYCIN250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H1250JIK0AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197516Internal RxNorm lookup
197517Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
99d2fd6b-39ca-42f9-ad06-30e7fbc22c47Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
e3d1ac4d-bee8-bcec-c4e6-12004dcb6ab2Product name720221114
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-616-60CLARITHROMYCIN60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-616-60EA - Each62135-6162678f3f9-a62a-43e6-8620-ef1082ed456f12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-616CLARITHROMYCIN TABLET, FILM COATED [CHARTWELL RX, LLC.]2Current NDC, Legacy NDC, 1 package rows20221224_99d2fd6b-39ca-42f9-ad06-30e7fbc22c47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197516clarithromycin 250 MG Oral TabletPSN99d2fd6b-39ca-42f9-ad06-30e7fbc22c472
197517clarithromycin 500 MG Oral TabletPSN99d2fd6b-39ca-42f9-ad06-30e7fbc22c472
197516clarithromycin 250 MG Oral TabletSCD99d2fd6b-39ca-42f9-ad06-30e7fbc22c472
197517clarithromycin 500 MG Oral TabletSCD99d2fd6b-39ca-42f9-ad06-30e7fbc22c472

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62135-616-606213506166060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-616-60) 2021-02-010000-00-00NoNoCurrent