Doxycycline Hyclate

Product NDC
33261-151
11-digit product format
332610151
Labeler code
33261
Product ID
33261-151_72aa6c88-0bac-469c-a1d8-4433c4f926b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA062396
Marketing category
ANDA
Marketing start
1984-05-07
Marketing end
0000-00-00
Substance
DOXYCYCLINE HYCLATE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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 · 9 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct33261-151IInactivated by FDA2026-08-03
excluded packagepackage33261-15133261-151-02IInactivated by FDA2026-08-03
excluded packagepackage33261-15133261-151-10IInactivated by FDA2026-08-03
excluded packagepackage33261-15133261-151-14IInactivated by FDA2026-08-03
excluded packagepackage33261-15133261-151-20IInactivated by FDA2026-08-03
excluded packagepackage33261-15133261-151-26IInactivated by FDA2026-08-03
excluded packagepackage33261-15133261-151-30IInactivated by FDA2026-08-03
excluded packagepackage33261-15133261-151-60IInactivated by FDA2026-08-03
excluded packagepackage33261-15133261-151-90IInactivated by FDA2026-08-03

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 4 · 198 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 productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-151-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-151-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-151-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-151-26d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-151-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-151-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-151-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-151-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-151-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-151-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-151-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-151-26f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-151-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-151-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-151-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-151-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-151-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-151-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-151-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-151-262ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-151-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-151-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-151-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-151-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-151-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-151-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-151-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-151-26a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-151-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-151-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-151-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-151-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-151-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-151-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-151-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-151-26cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-151-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-151-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-151-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-151-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-151-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-151-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-151-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-151-26cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-151-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-151-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-151-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-151-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-151-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-151-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-151-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-151-26302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-151-10302b2466d912…e7b80fea0513…

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
A062396-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-07
A062396-002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A062396-001AB
A062396-002AB

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 UTC2026-02A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALABRS1984-05-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062396-001DOXYCYCLINE HYCLATEEQ 100MG BASECAPSULE / ORALAB1984-05-07782e0a99824c…
2021-12-28 21:50 UTC2021-12A062396-002DOXYCYCLINE HYCLATEEQ 50MG BASECAPSULE / ORALAB1984-11-07782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A062396-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A062396-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062396-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062396-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A062396-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A062396-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062396-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062396-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062396-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062396-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062396-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062396-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062396-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062396-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062396-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062396-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062396-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062396-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062396-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A062396-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062396-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062396-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062396-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062396-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062396-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062396-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062396-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A062396-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062396-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062396-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062396-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A062396-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062396-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A062396-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062396-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A062396-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062396-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A062396-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062396-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A062396-002AB1782e0a99824c…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-151-02Doxycycline Hyclate120 in 1 BOTTLE, PLASTICCAPSULE1201
33261-151-10Doxycycline Hyclate10 in 1 BOTTLE, PLASTICCAPSULE101
33261-151-14Doxycycline Hyclate14 in 1 BOTTLE, PLASTICCAPSULE141
33261-151-20Doxycycline Hyclate20 in 1 BOTTLE, PLASTICCAPSULE201
33261-151-26Doxycycline Hyclate26 in 1 BOX, UNIT-DOSECAPSULE261
33261-151-30Doxycycline Hyclate30 in 1 BOTTLE, PLASTICCAPSULE301
33261-151-60Doxycycline Hyclate60 in 1 BOTTLE, PLASTICCAPSULE601
33261-151-90Doxycycline Hyclate90 in 1 BOTTLE, PLASTICCAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-151-02EA - Each33261-1518f64cb2d-56b8-429a-b5a5-cc199afdcc2912015-10-02
33261-151-14EA - Each33261-151dba38951-177d-4540-9824-1dd9be966bc512015-10-02
33261-151-20EA - Each33261-151ada1e22c-b2bd-4eb7-b739-c9f5ee1a3ffd12015-10-02
33261-151-30EA - Each33261-1510f9128be-c965-4330-9511-5b327600caab12015-10-02
33261-151-60EA - Each33261-151d7491d80-124e-488d-85a7-c2c0b2c2227212015-10-02
33261-151-90EA - Each33261-15124077226-8f4f-4b8e-9d01-27c66efd2df712015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOXYCYCLINE HYCLATEACTIVE INGREDIENT19XTS3T51UDOXYCYCLINE HYCLATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
DOXYCYCLINE ANHYDROUSACTIVE MOIETY334895S862DOXYCYCLINE HYCLATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOXYCYCLINE HYCLATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOXYCYCLINE HYCLATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDOXYCYCLINE HYCLATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOXYCYCLINE HYCLATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOXYCYCLINE HYCLATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDOXYCYCLINE HYCLATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOXYCYCLINE HYCLATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-151DOXYCYCLINE HYCLATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 8 package rows20120922_83cd3589-f0ec-43e3-93a8-4a69dc235244.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxycyclate HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.4dc319c1-b7ef-40e4-9e66-fb24cfdefea82026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEUnit Dose Solutions, Inc.548d4218-2feb-8716-e063-6394a90afbe32026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.e24a3292-0d4f-4692-8cf7-a82bd19e59322026-06-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEPD-Rx Pharmaceuticals, Inc.5f523294-e62b-4da5-8799-047d4bed966f2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATECoupler LLC52ba329a-8cb3-cf30-e063-6394a90aa0dc2026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEREMEDYREPACK INC.3a85933f-bd73-4ad7-968d-c90cb7c7a60c2026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATENorthwind Health Company, LLCf309ccbb-b68a-3190-e053-2995a90a0ad42026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEMajor Pharmaceuticalsc4aae81f-0219-450f-aa60-953964f741722025-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATENuCare Pharmaceuticals,Inc.8c525e4e-6e1b-4579-e053-2a95a90a43da2025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEAmerican Health Packaginge98d11b0-535f-4e57-9639-6358835c04bc2025-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEHikma Pharmaceuticals USA Inc.4ec4c8ca-ce83-4948-8626-21eb82ae5c192025-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATECoupler LLC325d5331-d48e-1bc4-e063-6394a90a65b92025-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
DoxycyclineDOXYCYCLINEDirect_Rx8c273efa-62ec-16b2-e053-2995a90ac41d2025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATEBryant Ranch Prepack214e5a5c-7f3e-478b-93d3-1713de9e76722024-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396
Doxycycline HyclateDOXYCYCLINE HYCLATENuCare Pharmaceuticals,Inc.88012cf8-509b-84cf-e053-2a95a90af3bc2024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062396
application number: ANDA062396

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1649988doxycycline hyclate 100 MG Oral CapsulePSN83cd3589-f0ec-43e3-93a8-4a69dc2352441
1649988doxycycline hyclate 100 MG Oral CapsuleSCD83cd3589-f0ec-43e3-93a8-4a69dc2352441
1649988doxycycline (as doxycycline hyclate) 100 MG Oral CapsuleSY83cd3589-f0ec-43e3-93a8-4a69dc2352441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-151-0233261015102120 in 1 BOTTLE, PLASTICHistorical
33261-151-103326101511010 in 1 BOTTLE, PLASTICHistorical
33261-151-143326101511414 in 1 BOTTLE, PLASTICHistorical
33261-151-203326101512020 in 1 BOTTLE, PLASTICHistorical
33261-151-263326101512626 in 1 BOX, UNIT-DOSEHistorical
33261-151-303326101513030 in 1 BOTTLE, PLASTICHistorical
33261-151-603326101516060 in 1 BOTTLE, PLASTICHistorical
33261-151-903326101519090 in 1 BOTTLE, PLASTICHistorical