FDA.reportPublic FDA data

DOXYCYCLINE HYCLATE

Product NDC
55488-0186
Requested package NDC
55488-0186-2
11-digit product format
554880186
Labeler code
55488
Product ID
55488-0186_47a38f08-ac1a-4c1d-97e6-086604822af4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE HYCLATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Changzhou Pharmaceutical Factory
Application
ANDA209402
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
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 packagepackage55488-018655488-0186-2IInactivated 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
A209402-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2019-10-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209402-001AB

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 22:54:322026-06A209402-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2019-10-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209402-001AB1a50c72e98297…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
doxycyclineDOXYCYCLINEPreferred Pharmaceuticals Inc.bcc95094-80ed-4023-b2a6-955a4810bfbe2026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209402
application number: ANDA209402
doxycyclineDOXYCYCLINEREMEDYREPACK INC.d3c0b756-30ba-4ef9-a178-fd785d7203732026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209402
application number: ANDA209402
doxycyclineDOXYCYCLINEREMEDYREPACK INC.f0fbf63a-e75c-40cf-b2e9-429deaac899d2026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209402
application number: ANDA209402
doxycyclineDOXYCYCLINEST. MARY'S MEDICAL PARK PHARMACY00b2aa98-dea2-90c3-e063-6294a90a35d62026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209402
application number: ANDA209402
doxycyclineDOXYCYCLINEPreferred Pharmaceuticals Inc.7f882f1a-fe75-4592-9df5-f0e4bf1d232e2026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209402
application number: ANDA209402
doxycyclineDOXYCYCLINEA-S Medication Solutions1c998ca8-1df6-4b3c-9533-f4500cc1079a2026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209402
application number: ANDA209402
doxycyclineDOXYCYCLINEA-S Medication Solutionsfe8cd3c6-36d6-4d92-bc5c-833cd6f9cb322026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209402
application number: ANDA209402
Doxycycline HyclateDOXYCYCLINE HYCLATEHealth Department, Oklahoma Statef39365f9-eb64-00cb-e053-2995a90a8d802025-12-31WarningsExact identifier
application applno (ANDA): 209402
application number: ANDA209402
doxycyclineDOXYCYCLINECranbury Pharmaceuticals, LLC43ceb0ee-268a-424c-a6a8-88e824c5ed042025-11-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209402
application number: ANDA209402
Doxycycline HyclateDOXYCYCLINE HYCLATEDiirect_rx1b403f4b-1c61-3991-e063-6394a90ae4f22024-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209402
application number: ANDA209402
doxycyclineDOXYCYCLINEBryant Ranch Prepack1df9e905-d2e7-4a5a-8bd6-43f4850ba9002024-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209402
application number: ANDA209402
doxycyclineDOXYCYCLINEProficient Rx LP716dccec-7480-44dd-91b9-249ae2c250882024-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209402
application number: ANDA209402
doxycyclineDOXYCYCLINEAsclemed USA, Inc.f33ae6f5-bdb6-4c15-9e62-6180433bb1fb2023-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209402
application number: ANDA209402

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
55488-0186-12022-01-28C16284748780-1d6a99b39-7db6-a426-e053-dadaa90af4c2DOXYCYCLINE HYCLATE CAPSULES - for oral use
55488-0186-22022-01-28C16284748780-1d6a99b39-7db6-a426-e053-dadaa90af4c2DOXYCYCLINE HYCLATE CAPSULES - for oral use

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55488-0186-1DOXYCYCLINE HYCLATE50 in 1 BOTTLECAPSULE502
55488-0186-2DOXYCYCLINE HYCLATE500 in 1 BOTTLECAPSULE5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55488-0186DOXYCYCLINE HYCLATE CAPSULE [CHANGZHOU PHARMACEUTICAL FACTORY]2Legacy NDC, 2 package rows20201029_045c1a20-4fe5-49b1-ad43-d92464e42ec7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN045c1a20-4fe5-49b1-ad43-d92464e42ec72
1649988doxycycline hyclate 100 MG Oral CapsuleSCD045c1a20-4fe5-49b1-ad43-d92464e42ec72
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY045c1a20-4fe5-49b1-ad43-d92464e42ec72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55488-0186-255488018602500 CAPSULE in 1 BOTTLE (55488-0186-2) 500 capsule2020-05-280000-00-00NoNoCurrent