FDA.reportPublic FDA data

DOXYCYCLINE HYCLATE

Product NDC
71335-9718
11-digit product format
713359718
Labeler code
71335
Product ID
71335-9718_fc8b60cd-4eb6-4a3e-91c3-e00650b38711
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE HYCLATE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211343
Marketing category
ANDA
Marketing start
2019-10-09
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
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
ndc (product): 71335-9718
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

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
1650143Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e726157e-ce44-4df3-8161-7016700dd751Available 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
71335-9718-1DOXYCYCLINE HYCLATE20 in 1 BOTTLETABLET20104
71335-9718-2DOXYCYCLINE HYCLATE30 in 1 BOTTLETABLET30104
71335-9718-3DOXYCYCLINE HYCLATE50 in 1 BOTTLETABLET50104
71335-9718-4DOXYCYCLINE HYCLATE14 in 1 BOTTLETABLET14104
71335-9718-5DOXYCYCLINE HYCLATE40 in 1 BOTTLETABLET40104
71335-9718-6DOXYCYCLINE HYCLATE60 in 1 BOTTLETABLET60104
71335-9718-7DOXYCYCLINE HYCLATE28 in 1 BOTTLETABLET28104
71335-9718-8DOXYCYCLINE HYCLATE10 in 1 BOTTLETABLET10104
71335-9718-9DOXYCYCLINE HYCLATE6 in 1 BOTTLETABLET6104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-9718-1EA - Each71335-9718931706a1-bfae-4ccf-9326-2d3bf997386d12023-09-05
71335-9718-4EA - Each71335-9718debde121-9773-4439-a4ba-3bdc2864d31212025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9718DOXYCYCLINE HYCLATE TABLET [BRYANT RANCH PREPACK]103Current NDC, 9 package rows20250330_e726157e-ce44-4df3-8161-7016700dd751.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSNe726157e-ce44-4df3-8161-7016700dd751104
1650143doxycycline hyclate 100 MG Oral TabletSCDe726157e-ce44-4df3-8161-7016700dd751104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9718-17133597180120 TABLET in 1 BOTTLE (71335-9718-1) 20 tablet2023-05-26NoNoCurrent
71335-9718-27133597180230 TABLET in 1 BOTTLE (71335-9718-2) 30 tablet2023-05-26NoNoCurrent
71335-9718-37133597180350 TABLET in 1 BOTTLE (71335-9718-3) 50 tablet2023-05-26NoNoCurrent
71335-9718-47133597180414 TABLET in 1 BOTTLE (71335-9718-4) 14 tablet2023-05-26NoNoCurrent
71335-9718-57133597180540 TABLET in 1 BOTTLE (71335-9718-5) 40 tablet2023-05-26NoNoCurrent
71335-9718-67133597180660 TABLET in 1 BOTTLE (71335-9718-6) 60 tablet2023-05-26NoNoCurrent
71335-9718-77133597180728 TABLET in 1 BOTTLE (71335-9718-7) 28 tablet2023-05-26NoNoCurrent
71335-9718-87133597180810 TABLET in 1 BOTTLE (71335-9718-8) 10 tablet2023-05-26NoNoCurrent
71335-9718-9713359718096 TABLET in 1 BOTTLE (71335-9718-9) 6 tablet2023-05-26NoNoCurrent