Doxycycline Hyclate

Product NDC
70518-3214
11-digit product format
705183214
Labeler code
70518
Product ID
70518-3214_4ecf4677-2424-6125-e063-6294a90afa47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA062269
Marketing category
ANDA
Marketing start
2021-09-08
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-321470518-3214-0DDiscontinued by firm2026-08-07
excluded packagepackage70518-321470518-3214-1DDiscontinued by firm2026-08-07
excluded packagepackage70518-321470518-3214-2DDiscontinued by firm2026-08-07
excluded packagepackage70518-321470518-3214-3DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 43 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-3214-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-3214-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-3214-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-3214-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-3214-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-3214-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-3214-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-3214-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-3214-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-3214-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-3214-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-3214-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-3214-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-3214-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-3214-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-3214-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-3214-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-3214-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-3214-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-3214-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-3214-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-3214-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-3214-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-3214-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-3214-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-3214-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-3214-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-3214-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-3214-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-3214-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-3214-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-3214-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-3214-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-3214-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-3214-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-3214-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-3214-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-3214-0367a005e9d99…383a685ebd0f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A062269-002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08
A062269-003DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A062269-002AB
A062269-003AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08d06236e962d9…
2024-10-29 15:01 UTC2024-10A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-081e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-088072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-085c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-085d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-084b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALAB1982-11-0874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORAL1983-10-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062269-002DOXYCYCLINE HYCLATEEQ 100MG BASETABLET / ORALABRS1982-11-08782e0a99824c…
2021-12-28 21:50 UTC2021-12A062269-003DOXYCYCLINE HYCLATEEQ 50MG BASETABLET / ORALAB1983-10-05782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A062269-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062269-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062269-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062269-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062269-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062269-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062269-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062269-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062269-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062269-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062269-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062269-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062269-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062269-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062269-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062269-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062269-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062269-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062269-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062269-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062269-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062269-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062269-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062269-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062269-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062269-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062269-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062269-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062269-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062269-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062269-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062269-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062269-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062269-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062269-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062269-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062269-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062269-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A062269-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062269-002AB187673890dc5c…

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
2305ab4a-7d08-41f6-9c39-c9b6835be389Available 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
70518-3214-0Doxycycline Hyclate14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1411
70518-3214-1Doxycycline Hyclate20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2011
70518-3214-2Doxycycline Hyclate14 in 1 BOTTLE, PLASTICTABLET, FILM COATED1411
70518-3214-3Doxycycline Hyclate2 in 1 BOXTABLET, FILM COATED211
70518-3214-4Doxycycline Hyclate1 in 1 POUCHTABLET, FILM COATED111
70518-3214-5Doxycycline Hyclate10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3214DOXYCYCLINE HYCLATE TABLET, FILM COATED [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 6 package rows20250206_2305ab4a-7d08-41f6-9c39-c9b6835be389.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 HYCLATEREMEDYREPACK INC.2305ab4a-7d08-41f6-9c39-c9b6835be3892026-04-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
ndc (product): 70518-3214
Doxycycline HyclateDOXYCYCLINE HYCLATEHealth Department, Oklahoma Statef39365f9-eb64-00cb-e053-2995a90a8d802025-12-31WarningsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATERedpharm Drug44f2fdde-cf84-6f42-e063-6394a90af94e2025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEA-S Medication Solutionsca63aa91-519d-429f-adfc-a4ec453672942025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.051654c7-8ba6-44f2-842c-72f515e9b32d2025-10-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
TARGADOXDOXYCYCLINE HYCLATEJourney Medical Corporation83243f78-b984-46a4-a88a-c6a15c217b902025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEJG Pharma Inc.10b8bf71-4311-41e8-a891-bab8bc86863f2025-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEA-S Medication Solutions61195fc6-3fa7-4203-b526-477b483958562025-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEA-S Medication Solutions9cbd8699-e2c2-40d4-8797-e676f2a10eb22025-05-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS65cac0b6-3550-48cf-bffa-cf42443c27312025-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATEEpic Pharma, LLC2b402587-8ecc-4fea-83ad-8071345b63562025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269
Doxycycline HyclateDOXYCYCLINE HYCLATENuCare Pharmaceuticals,Inc.860a1566-5857-ed88-e053-2991aa0ae2a42024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062269
application number: ANDA062269

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1650143doxycycline hyclate 100 MG Oral TabletPSN2305ab4a-7d08-41f6-9c39-c9b6835be38911
1650143doxycycline hyclate 100 MG Oral TabletSCD2305ab4a-7d08-41f6-9c39-c9b6835be38911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3214-07051832140014 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3214-0) 2021-09-080000-00-00NoNoCurrent
70518-3214-17051832140120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3214-1) 2022-03-300000-00-00NoNoCurrent
70518-3214-27051832140214 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3214-2) 2022-07-260000-00-00NoNoCurrent
70518-3214-3705183214032 in 1 BOXHistorical
70518-3214-4705183214041 in 1 POUCHHistorical
70518-3214-57051832140510 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3214-5) 2025-01-30NoNoCurrent