FDA.reportPublic FDA data

Doxycycline Hyclate

Product NDC
60219-1100
11-digit product format
602191100
Labeler code
60219
Product ID
60219-1100_d114fe27-0716-4e35-be8d-e69bd5a3cbb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA207289
Marketing category
ANDA
Marketing start
2016-06-28
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207289-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207289-001AB

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 22:54:322026-06A207289-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB2016-06-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207289-001AB1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxycycline HyclateDOXYCYCLINEBryant Ranch Prepackf9a9a558-4063-4aa7-9191-3875c97cf49a2025-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207289
application number: ANDA207289
Doxycycline HyclateDOXYCYCLINEAmneal Pharmaceuticals NY LLC49ecbf95-58e8-4f3c-b5d5-650a15d866cb2025-09-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207289
application number: ANDA207289
ndc (product): 60219-1100
Doxycycline HyclateDOXYCYCLINEAmneal Pharmaceuticals NY LLC79f3c026-7687-4a11-8d2e-03493531d3bf2025-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207289
application number: ANDA207289
Doxycycline HyclateDOXYCYCLINE HYCLATEAdvanced Rx Pharmacy of Tennessee, LLCb4f2ab4f-c32b-6435-e053-2995a90a69b62024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207289
application number: ANDA207289
Doxycycline HyclateDOXYCYCLINEProficient Rx LPe2151005-fb4a-485d-88ad-b44c4594d5792022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207289
application number: ANDA207289

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYCYCLINE HYCLATE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
19XTS3T51UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1649988Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
49ecbf95-58e8-4f3c-b5d5-650a15d866cbAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60219-1100-1Doxycycline Hyclate100 in 1 BOTTLECAPSULE10013
60219-1100-3Doxycycline Hyclate20 in 1 BOTTLECAPSULE2013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-1100DOXYCYCLINE HYCLATE (DOXYCYCLINE) CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]12Current NDC, Legacy NDC, 2 package rows20231229_49ecbf95-58e8-4f3c-b5d5-650a15d866cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN49ecbf95-58e8-4f3c-b5d5-650a15d866cb13
1649988doxycycline hyclate 100 MG Oral CapsuleSCD49ecbf95-58e8-4f3c-b5d5-650a15d866cb13
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY49ecbf95-58e8-4f3c-b5d5-650a15d866cb13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60219-1100-160219110001100 CAPSULE in 1 BOTTLE (60219-1100-1) 100 capsule2016-06-280000-00-00NoNoCurrent
60219-1100-36021911000320 CAPSULE in 1 BOTTLE (60219-1100-3) 20 capsule2016-06-280000-00-00NoNoCurrent