FDA.reportPublic FDA data

doxycycline

Product NDC
27808-233
11-digit product format
278080233
Labeler code
27808
Product ID
27808-233_916c7c28-037e-40aa-a97f-d9d5c4fc43f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxycycline
Dosage form
CAPSULE
Route
ORAL
Labeler
Cranbury Pharmaceuticals, LLC
Application
ANDA209402
Marketing category
ANDA
Marketing start
2021-11-19
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
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
ndc (product): 27808-233
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

Additional Listing Data#

Finished product
Yes
Brand name base
doxycycline
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
43ceb0ee-268a-424c-a6a8-88e824c5ed04Available 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
27808-233-01doxycycline50 in 1 BOTTLECAPSULE507
27808-233-02doxycycline500 in 1 BOTTLECAPSULE5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27808-233-01EA - Each27808-233f5c97029-987d-49c3-a452-3f3d73cd25b312022-01-06
27808-233-02EA - Each27808-233b2d40603-9140-4de4-bdb5-da6f8d84713212022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27808-233DOXYCYCLINE CAPSULE [TRIS PHARMA INC]3Current NDC, Legacy NDC, 2 package rows20211201_43ceb0ee-268a-424c-a6a8-88e824c5ed04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN1df9e905-d2e7-4a5a-8bd6-43f4850ba900103
1649988doxycycline hyclate 100 MG Oral CapsuleSCD1df9e905-d2e7-4a5a-8bd6-43f4850ba900103
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY1df9e905-d2e7-4a5a-8bd6-43f4850ba900103
1649988doxycycline hyclate 100 MG Oral CapsulePSNf0fbf63a-e75c-40cf-b2e9-429deaac899d18
1649988doxycycline hyclate 100 MG Oral CapsuleSCDf0fbf63a-e75c-40cf-b2e9-429deaac899d18
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYf0fbf63a-e75c-40cf-b2e9-429deaac899d18
1649988doxycycline hyclate 100 MG Oral CapsulePSN43ceb0ee-268a-424c-a6a8-88e824c5ed047
1649988doxycycline hyclate 100 MG Oral CapsuleSCD43ceb0ee-268a-424c-a6a8-88e824c5ed047
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY43ceb0ee-268a-424c-a6a8-88e824c5ed047
1649988doxycycline hyclate 100 MG Oral CapsulePSNe0900646-20f0-2f67-e053-2995a90a10486
1649988doxycycline hyclate 100 MG Oral CapsuleSCDe0900646-20f0-2f67-e053-2995a90a10486
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYe0900646-20f0-2f67-e053-2995a90a10486
1649988doxycycline hyclate 100 MG Oral CapsulePSNe1929645-2cca-7f9d-e053-2a95a90a6d855
1649988doxycycline hyclate 100 MG Oral CapsuleSCDe1929645-2cca-7f9d-e053-2a95a90a6d855
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYe1929645-2cca-7f9d-e053-2a95a90a6d855
1649988doxycycline hyclate 100 MG Oral CapsulePSNf39365f9-eb64-00cb-e053-2995a90a8d804
1650143doxycycline hyclate 100 MG Oral TabletPSNf39365f9-eb64-00cb-e053-2995a90a8d804
1649988doxycycline hyclate 100 MG Oral CapsuleSCDf39365f9-eb64-00cb-e053-2995a90a8d804
1650143doxycycline hyclate 100 MG Oral TabletSCDf39365f9-eb64-00cb-e053-2995a90a8d804
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYf39365f9-eb64-00cb-e053-2995a90a8d804
1649988doxycycline hyclate 100 MG Oral CapsulePSN7f882f1a-fe75-4592-9df5-f0e4bf1d232e3
1649988doxycycline hyclate 100 MG Oral CapsulePSN1c998ca8-1df6-4b3c-9533-f4500cc1079a3
1649988doxycycline hyclate 100 MG Oral CapsulePSNfe8cd3c6-36d6-4d92-bc5c-833cd6f9cb323
1649988doxycycline hyclate 100 MG Oral CapsulePSN00b2aa98-dea2-90c3-e063-6294a90a35d63
1649988doxycycline hyclate 100 MG Oral CapsuleSCD00b2aa98-dea2-90c3-e063-6294a90a35d63
1649988doxycycline hyclate 100 MG Oral CapsuleSCDfe8cd3c6-36d6-4d92-bc5c-833cd6f9cb323
1649988doxycycline hyclate 100 MG Oral CapsuleSCD7f882f1a-fe75-4592-9df5-f0e4bf1d232e3
1649988doxycycline hyclate 100 MG Oral CapsuleSCD1c998ca8-1df6-4b3c-9533-f4500cc1079a3
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY00b2aa98-dea2-90c3-e063-6294a90a35d63
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYfe8cd3c6-36d6-4d92-bc5c-833cd6f9cb323
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY7f882f1a-fe75-4592-9df5-f0e4bf1d232e3
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY1c998ca8-1df6-4b3c-9533-f4500cc1079a3
1649988doxycycline hyclate 100 MG Oral CapsulePSN1b403f4b-1c61-3991-e063-6394a90ae4f22
1649988doxycycline hyclate 100 MG Oral CapsulePSN09d198e7-85b6-631c-e063-6294a90adb202
1649988doxycycline hyclate 100 MG Oral CapsulePSN716dccec-7480-44dd-91b9-249ae2c250882
1649988doxycycline hyclate 100 MG Oral CapsulePSNd3c0b756-30ba-4ef9-a178-fd785d7203732
1649988doxycycline hyclate 100 MG Oral CapsuleSCD1b403f4b-1c61-3991-e063-6394a90ae4f22
1649988doxycycline hyclate 100 MG Oral CapsuleSCD716dccec-7480-44dd-91b9-249ae2c250882
1649988doxycycline hyclate 100 MG Oral CapsuleSCD09d198e7-85b6-631c-e063-6294a90adb202
1649988doxycycline hyclate 100 MG Oral CapsuleSCDd3c0b756-30ba-4ef9-a178-fd785d7203732
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY716dccec-7480-44dd-91b9-249ae2c250882
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY1b403f4b-1c61-3991-e063-6394a90ae4f22
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY09d198e7-85b6-631c-e063-6294a90adb202
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYd3c0b756-30ba-4ef9-a178-fd785d7203732
1649988doxycycline hyclate 100 MG Oral CapsulePSNf33ae6f5-bdb6-4c15-9e62-6180433bb1fb1
1649988doxycycline hyclate 100 MG Oral CapsulePSN1496c935-b2dc-e1e4-e063-6394a90a1e491
1649988doxycycline hyclate 100 MG Oral CapsuleSCDf33ae6f5-bdb6-4c15-9e62-6180433bb1fb1
1649988doxycycline hyclate 100 MG Oral CapsuleSCD1496c935-b2dc-e1e4-e063-6394a90a1e491
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSYf33ae6f5-bdb6-4c15-9e62-6180433bb1fb1
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY1496c935-b2dc-e1e4-e063-6394a90a1e491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27808-233-012780802330150 CAPSULE in 1 BOTTLE (27808-233-01) 50 capsule2021-11-230000-00-00NoNoCurrent
27808-233-0227808023302500 CAPSULE in 1 BOTTLE (27808-233-02) 500 capsule2021-11-230000-00-00NoNoCurrent