FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
42582-215
Requested package NDC
42582-215-05
11-digit product format
425820215
Labeler code
42582
Product ID
42582-215_fc04d0bc-e56a-464a-9e69-17dd48d392f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bi-Coastal Pharma International, LLC
Application
ANDA211343
Marketing category
ANDA
Marketing start
2020-05-28
Marketing end
0000-00-00
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42582-21542582-215-05IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211343-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211343-001AB

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 22:54:322026-06A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211343-001AB1a50c72e98297…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATESt. Mary's Medical Park Pharmacy02f87c60-8425-1a1e-e063-6294a90a0c942026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211343
application number: ANDA211343
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEREMEDYREPACK INC.5fdc01c3-c62f-40cf-8351-91cbcc43d3792026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211343
application number: ANDA211343
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEBryant Ranch Prepack7a915c50-6fce-45e6-9554-677bb09a868d2026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211343
application number: ANDA211343
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATECranbury Pharmaceuticals, LLCfe6985d2-37f7-4277-94a9-f7125b4b3fd72026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211343
application number: ANDA211343
Doxycycline HyclateDOXYCYCLINE HYCLATEDirect_Rx2ad2b85f-2479-c7cd-e063-6294a90acca12026-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211343
application number: ANDA211343
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEREMEDYREPACK INC.d421b771-de88-4769-949f-8a24baa69c252026-01-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211343
application number: ANDA211343
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEBryant Ranch Prepacke726157e-ce44-4df3-8161-7016700dd7512025-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211343
application number: ANDA211343
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATERedpharm Drug1a3c713f-bc4f-4848-e063-6394a90a02722025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211343
application number: ANDA211343
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATERedpharm Drug0b251a58-30d8-dfec-e063-6294a90a3b452025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211343
application number: ANDA211343
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEBryant Ranch Prepackfd58dbe5-aab2-4378-b054-d5c60d87074e2024-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211343
application number: ANDA211343
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATENuCare Pharmaceuticals,Inc.0106a3d3-db4d-f6ee-e063-6294a90a25e92024-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211343
application number: ANDA211343
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEProficient Rx LPe38f3cd2-47e5-438f-bbe3-50b578360f742024-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211343
application number: ANDA211343

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b4321c75-2e87-4d90-9726-9a28fb2293a3Product name320260112
5e99724e-0654-4aec-b7a2-0b9b10e312eeProduct name320250227
d2d36660-68ce-7e7d-0630-ec4b0d859fadProduct name620220921
a239f4dd-cf93-4660-b190-f97d000f249fProduct name720210607
a9d03566-caeb-4466-8021-74599b048880Product name320210604
12750814-20f7-4f35-b5fa-dbc8811ba858Product name920201007
00a5dbaa-1b7d-4e56-be0c-fedc7bbf5adeProduct name120200706
7b4b06ac-8c50-45f0-9556-293ea558a294Product name120180808
6a5b4392-5ab0-af0d-e0be-47b34e9dbb84Product name520171121
01a4aa74-7e05-63bd-bc10-1b5ceb111371Product name220171115
58b1278c-6dce-49b6-a05e-ea16f389acbaProduct name120160620

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42582-215-052023-01-30C16284748780-1f386c64a-0f79-0266-e053-dadaa90a7c1aDOXYCYCLINE HYCLATE TABLETS, USP
42582-215-182023-01-30C16284748780-1f386c64a-0f79-0266-e053-dadaa90a7c1aDOXYCYCLINE HYCLATE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42582-215-05Doxycycline Hyclate50 in 1 BOTTLETABLET, COATED503
42582-215-18Doxycycline Hyclate500 in 1 BOTTLETABLET, COATED5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42582-215DOXYCYCLINE HYCLATE TABLET, COATED [BI-COASTAL PHARMA INTERNATIONAL, LLC]3Legacy NDC, 2 package rows20210327_4ee17bbb-29ba-49ce-8f81-748879831314.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN4ee17bbb-29ba-49ce-8f81-7488798313143
1650143doxycycline hyclate 100 MG Oral TabletSCD4ee17bbb-29ba-49ce-8f81-7488798313143

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42582-215-054258202150550 TABLET, COATED in 1 BOTTLE (42582-215-05) 2020-05-280000-00-00NoNoCurrent