Doxycycline Hyclate

Product NDC
72789-276
11-digit product format
727890276
Labeler code
72789
Product ID
72789-276_3ccd8245-6963-e76b-e063-6394a90aa6b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA062677
Marketing category
ANDA
Marketing start
1986-07-10
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
A062677-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062677-001AB

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-103f01610625f2…
2019-09-15 20:21 UTC2019-09A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062677-001DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1986-07-10cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A062677-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062677-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062677-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062677-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062677-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062677-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062677-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062677-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062677-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062677-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062677-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062677-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062677-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062677-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062677-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062677-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062677-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062677-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062677-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062677-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062677-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A062677-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062677-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062677-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062677-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A062677-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A062677-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062677-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062677-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062677-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062677-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062677-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062677-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062677-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A062677-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A062677-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062677-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062677-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062677-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062677-001AB1cb3db0bc1861…

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
1401d590-0967-4c6b-b52b-a83e9f6df097Available 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
72789-276-01Doxycycline Hyclate100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10043
72789-276-07Doxycycline Hyclate7 in 1 BOTTLE, PLASTICTABLET, FILM COATED743
72789-276-10Doxycycline Hyclate10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1043
72789-276-14Doxycycline Hyclate14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1443
72789-276-20Doxycycline Hyclate20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2043
72789-276-28Doxycycline Hyclate28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2843
72789-276-71Doxycycline Hyclate210 in 1 BOTTLE, PLASTICTABLET, FILM COATED21043
72789-276-74Doxycycline Hyclate400 in 1 BOTTLE, PLASTICTABLET, FILM COATED40043
72789-276-82Doxycycline Hyclate500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50043
72789-276-85Doxycycline Hyclate330 in 1 BOTTLE, PLASTICTABLET, FILM COATED33043
72789-276-87Doxycycline Hyclate300 in 1 BOTTLE, PLASTICTABLET, FILM COATED30043
72789-276-90Doxycycline Hyclate90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9043
72789-276-93Doxycycline Hyclate180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18043

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-276-01EA - Each72789-276bc3d9739-7b11-4475-8f4a-f8c7afd96a3212024-02-14
72789-276-07EA - Each72789-27636ddb714-6e8b-48b3-9a0f-e64a6a5aa7f912024-02-14
72789-276-10EA - Each72789-2767cb7b921-84ab-4fc8-b6aa-cf980b47cb3212023-08-08
72789-276-14EA - Each72789-2763774da5e-13f4-45e2-a88f-a8602150e88c12023-01-09
72789-276-20EA - Each72789-27670a14668-ec7d-4664-9f69-6f2260f84e3712023-01-09
72789-276-28EA - Each72789-276eaf27e93-f728-4531-94ac-f3cc14422a1012025-09-12
72789-276-71EA - Each72789-2764ad981fa-a388-44c8-9527-dde69657fee412023-02-06
72789-276-74EA - Each72789-276e574ed77-585d-4d37-b20a-a3df8e04598312023-02-06
72789-276-82EA - Each72789-27672490a10-dd52-491f-8947-4a222376e5cf12022-11-07
72789-276-85EA - Each72789-2761871fccb-6651-4887-bb3f-7035f697dc5012024-04-05
72789-276-87EA - Each72789-276a16baa97-2dcf-47f8-b467-1c3a5259a59312023-04-07
72789-276-90EA - Each72789-27629f2207e-562b-4bcb-9787-69b6282e294512023-02-06
72789-276-93EA - Each72789-276e0674a1e-23d8-48c9-83e2-d3be1661b88b12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-276DOXYCYCLINE HYCLATE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]40Current NDC, Legacy NDC, 13 package rows20250223_1401d590-0967-4c6b-b52b-a83e9f6df097.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.c8194d6e-c407-465e-a342-4d2d9756dfc42026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062677
application number: ANDA062677
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.cf95b2ca-2cf8-49a8-8e3a-f9b0f5b2072c2026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062677
application number: ANDA062677
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.3af9348c-a98b-4059-a5ef-4229e2b33af02026-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062677
application number: ANDA062677
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.1401d590-0967-4c6b-b52b-a83e9f6df0972026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062677
application number: ANDA062677
ndc (product): 72789-276
Doxycycline HyclateDOXYCYCLINE HYCLATESun Pharmaceutical Industries, Inc.214a9cfe-a522-4022-81d4-e59f447401fe2026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062677
application number: ANDA062677
Doxycycline HyclateDOXYCYCLINE HYCLATEAvPAK53ff9f7e-0db0-c841-d334-4cf31f6588282025-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062677
application number: ANDA062677

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN1401d590-0967-4c6b-b52b-a83e9f6df09743
1650143doxycycline hyclate 100 MG Oral TabletSCD1401d590-0967-4c6b-b52b-a83e9f6df09743

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-276-0172789027601100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-01) 2024-01-19NoNoCurrent
72789-276-07727890276077 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-07) 2024-01-19NoNoCurrent
72789-276-107278902761010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-10) 2023-07-13NoNoCurrent
72789-276-147278902761414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-14) 2022-11-180000-00-00NoNoCurrent
72789-276-207278902762020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-20) 2022-11-170000-00-00NoNoCurrent
72789-276-287278902762828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-28) 2025-08-20NoNoCurrent
72789-276-7172789027671210 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-71) 2023-01-17NoNoCurrent
72789-276-7472789027674400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-74) 2023-01-17NoNoCurrent
72789-276-8272789027682500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-82) 2022-10-070000-00-00NoNoCurrent
72789-276-8572789027685330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-85) 2024-02-20NoNoCurrent
72789-276-8772789027687300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-87) 2023-03-02NoNoCurrent
72789-276-907278902769090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-90) 2023-01-17NoNoCurrent
72789-276-9372789027693180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-276-93) 2023-01-17NoNoCurrent