FDA.reportPublic FDA data

DOXYCYCLINE HYCLATE

Product NDC
55488-0185
Requested package NDC
55488-0185-1
11-digit product format
554880185
Labeler code
55488
Product ID
55488-0185_5431bb85-f36f-4286-9597-9ff0049588d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE HYCLATE
Dosage form
TABLET
Route
ORAL
Labeler
Changzhou Pharmaceutical Factory
Application
ANDA211343
Marketing category
ANDA
Marketing start
2020-01-01
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
2021-12-31
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 packagepackage55488-018555488-0185-1IInactivated by FDA2026-08-03

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
55488-0185-12022-01-28C16284748780-1d6a99b39-3e8a-a426-e053-dadaa90af4c2DOXYCYCLINE HYCLATE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55488-0185-1DOXYCYCLINE HYCLATE50 in 1 BOTTLETABLET501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55488-0185DOXYCYCLINE HYCLATE TABLET [CHANGZHOU PHARMACEUTICAL FACTORY]1Legacy NDC, 1 package rows20200529_003dd45b-1e86-4261-8bf8-f572414b59a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN003dd45b-1e86-4261-8bf8-f572414b59a61
1650143doxycycline hyclate 100 MG Oral TabletSCD003dd45b-1e86-4261-8bf8-f572414b59a61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55488-0185-15548801850150 TABLET in 1 BOTTLE (55488-0185-1) 50 tablet2020-01-010000-00-00NoNoCurrent