DOXYCYCLINE HYCLATE

Product NDC
27808-234
11-digit product format
278080234
Labeler code
27808
Product ID
27808-234_03cb5078-768e-41a1-b922-f1dee98e8760
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DOXYCYCLINE HYCLATE
Dosage form
TABLET
Route
ORAL
Labeler
Cranbury Pharmaceuticals, LLC
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 42.

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
2026-08-18 06:07:402026-07A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-093f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-09cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211343-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB2019-10-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A211343-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211343-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211343-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211343-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211343-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211343-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211343-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211343-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211343-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211343-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211343-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211343-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211343-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211343-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211343-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211343-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211343-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211343-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211343-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211343-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211343-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211343-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A211343-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211343-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211343-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211343-001AB13f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211343-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211343-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211343-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211343-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211343-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211343-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211343-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A211343-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A211343-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211343-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211343-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211343-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211343-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211343-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
DOXYCYCLINE HYCLATE
Listing expiration
2027-12-31

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
fe6985d2-37f7-4277-94a9-f7125b4b3fd7Available 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27808-234-01DOXYCYCLINE HYCLATE50 in 1 BOTTLETABLET502
27808-234-02DOXYCYCLINE HYCLATE500 in 1 BOTTLETABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27808-234-01EA - Each27808-234a33a57a2-ee39-44b1-954f-21d52ce4299612022-04-06
27808-234-02EA - Each27808-234ef1ccbe8-63f1-4f95-8c7e-2af61232250c12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27808-234DOXYCYCLINE HYCLATE TABLET [TRIS PHARMA INC]1Current NDC, Legacy NDC, 2 package rows20220215_fe6985d2-37f7-4277-94a9-f7125b4b3fd7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATENuCare Pharmaceuticals,Inc.0106a3d3-db4d-f6ee-e063-6294a90a25e92026-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211343
application number: ANDA211343
DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEREMEDYREPACK INC.5fdc01c3-c62f-40cf-8351-91cbcc43d3792026-08-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211343
application number: ANDA211343
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 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
ndc (product): 27808-234
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 HYCLATEProficient Rx LPe38f3cd2-47e5-438f-bbe3-50b578360f742024-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211343
application number: ANDA211343

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
1650143doxycycline hyclate 100 MG Oral TabletPSNfd58dbe5-aab2-4378-b054-d5c60d87074e100
1650143doxycycline hyclate 100 MG Oral TabletPSN7a915c50-6fce-45e6-9554-677bb09a868d100
1650143doxycycline hyclate 100 MG Oral TabletSCDfd58dbe5-aab2-4378-b054-d5c60d87074e100
1650143doxycycline hyclate 100 MG Oral TabletSCD7a915c50-6fce-45e6-9554-677bb09a868d100
1650143doxycycline hyclate 100 MG Oral TabletPSN5fdc01c3-c62f-40cf-8351-91cbcc43d37913
1650143doxycycline hyclate 100 MG Oral TabletSCD5fdc01c3-c62f-40cf-8351-91cbcc43d37913
1650143doxycycline hyclate 100 MG Oral TabletPSN0106a3d3-db4d-f6ee-e063-6294a90a25e93
1650143doxycycline hyclate 100 MG Oral TabletPSN02f87c60-8425-1a1e-e063-6294a90a0c943
1650143doxycycline hyclate 100 MG Oral TabletPSN1a3c713f-bc4f-4848-e063-6394a90a02723
1650143doxycycline hyclate 100 MG Oral TabletSCD02f87c60-8425-1a1e-e063-6294a90a0c943
1650143doxycycline hyclate 100 MG Oral TabletSCD0106a3d3-db4d-f6ee-e063-6294a90a25e93
1650143doxycycline hyclate 100 MG Oral TabletSCD1a3c713f-bc4f-4848-e063-6394a90a02723
1650143doxycycline hyclate 100 MG Oral TabletPSNfe6985d2-37f7-4277-94a9-f7125b4b3fd72
1650143doxycycline hyclate 100 MG Oral TabletPSNdb521288-b67d-48fd-9d07-3e7f301e60cd2
1650143doxycycline hyclate 100 MG Oral TabletPSN2ad2b85f-2479-c7cd-e063-6294a90acca12
1650143doxycycline hyclate 100 MG Oral TabletPSN0b251a58-30d8-dfec-e063-6294a90a3b452
1650143doxycycline hyclate 100 MG Oral TabletSCDdb521288-b67d-48fd-9d07-3e7f301e60cd2
1650143doxycycline hyclate 100 MG Oral TabletSCD2ad2b85f-2479-c7cd-e063-6294a90acca12
1650143doxycycline hyclate 100 MG Oral TabletSCDfe6985d2-37f7-4277-94a9-f7125b4b3fd72
1650143doxycycline hyclate 100 MG Oral TabletSCD0b251a58-30d8-dfec-e063-6294a90a3b452
1650143doxycycline hyclate 100 MG Oral TabletPSNd421b771-de88-4769-949f-8a24baa69c251
1650143doxycycline hyclate 100 MG Oral TabletPSNe38f3cd2-47e5-438f-bbe3-50b578360f741
1650143doxycycline hyclate 100 MG Oral TabletPSN97d25310-d19f-4bde-a03e-d464ebb2a6bf1
1650143doxycycline hyclate 100 MG Oral TabletSCDd421b771-de88-4769-949f-8a24baa69c251
1650143doxycycline hyclate 100 MG Oral TabletSCD97d25310-d19f-4bde-a03e-d464ebb2a6bf1
1650143doxycycline hyclate 100 MG Oral TabletSCDe38f3cd2-47e5-438f-bbe3-50b578360f741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27808-234-012780802340150 TABLET in 1 BOTTLE (27808-234-01) 50 tablet2022-02-140000-00-00NoNoCurrent
27808-234-0227808023402500 TABLET in 1 BOTTLE (27808-234-02) 500 tablet2022-02-140000-00-00NoNoCurrent