Doxycycline Hyclate

Product NDC
60505-4384
11-digit product format
605054384
Labeler code
60505
Product ID
60505-4384_8f2020b8-f616-ceae-c7f2-099819460d76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxycycline Hyclate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA209243
Marketing category
ANDA
Marketing start
2019-08-01
Marketing end
0000-00-00
Substance
DOXYCYCLINE HYCLATE
Active strength
150 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60505-4384DDiscontinued by firm2026-10-05
excluded packagepackage60505-438460505-4384-1DDiscontinued by firm2026-10-05
excluded packagepackage60505-438460505-4384-5DDiscontinued by firm2026-10-05
excluded packagepackage60505-438460505-4384-6DDiscontinued by firm2026-10-05

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0560505-4384-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0560505-4384-5d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2660505-4384-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2660505-4384-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3160505-4384-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3160505-4384-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2860505-4384-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2860505-4384-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2160505-4384-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2160505-4384-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1060505-4384-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1060505-4384-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3160505-4384-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3160505-4384-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2060505-4384-5ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2060505-4384-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1060505-4384-50efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1060505-4384-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0860505-4384-5ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0860505-4384-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0360505-4384-5367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0360505-4384-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0960505-4384-5557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0960505-4384-1557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A209243-001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 75MG BASETABLET / ORAL2019-04-15
A209243-002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEEQ 150MG BASETABLET / ORAL2019-04-15

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A209243-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET / ORAL2019-04-1584e616aacf4f…
2026-09-14 22:38:342026-08A209243-002DOXYCYCLINE HYCLATEEQ 150MG BASETABLET / ORAL2019-04-1584e616aacf4f…
2026-08-18 06:07:402026-07A209243-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET / ORAL2019-04-15caaa826d4ba7…
2026-08-18 06:07:402026-07A209243-002DOXYCYCLINE HYCLATEEQ 150MG BASETABLET / ORAL2019-04-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209243-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET / ORAL2019-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209243-002DOXYCYCLINE HYCLATEEQ 150MG BASETABLET / ORAL2019-04-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209243-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET / ORALAB2019-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209243-002DOXYCYCLINE HYCLATEEQ 150MG BASETABLET / ORALAB2019-04-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A209243-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET / ORALAB2019-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209243-002DOXYCYCLINE HYCLATEEQ 150MG BASETABLET / ORALAB2019-04-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209243-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET / ORALAB2019-04-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209243-002DOXYCYCLINE HYCLATEEQ 150MG BASETABLET / ORALAB2019-04-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209243-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET / ORALAB2019-04-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209243-002DOXYCYCLINE HYCLATEEQ 150MG BASETABLET / ORALAB2019-04-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209243-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET / ORALAB2019-04-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209243-002DOXYCYCLINE HYCLATEEQ 150MG BASETABLET / ORALAB2019-04-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209243-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET / ORALAB2019-04-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209243-002DOXYCYCLINE HYCLATEEQ 150MG BASETABLET / ORALAB2019-04-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209243-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET / ORALAB2019-04-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209243-002DOXYCYCLINE HYCLATEEQ 150MG BASETABLET / ORALAB2019-04-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209243-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET / ORALAB2019-04-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209243-002DOXYCYCLINE HYCLATEEQ 150MG BASETABLET / ORALAB2019-04-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209243-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET / ORALAB2019-04-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A209243-002DOXYCYCLINE HYCLATEEQ 150MG BASETABLET / ORALAB2019-04-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209243-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET / ORALAB2019-04-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209243-002DOXYCYCLINE HYCLATEEQ 150MG BASETABLET / ORALAB2019-04-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209243-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET / ORALAB2019-04-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209243-002DOXYCYCLINE HYCLATEEQ 150MG BASETABLET / ORALAB2019-04-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209243-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET / ORALAB2019-04-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209243-002DOXYCYCLINE HYCLATEEQ 150MG BASETABLET / ORALAB2019-04-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209243-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET / ORALAB2019-04-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209243-002DOXYCYCLINE HYCLATEEQ 150MG BASETABLET / ORALAB2019-04-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209243-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET / ORALAB2019-04-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209243-002DOXYCYCLINE HYCLATEEQ 150MG BASETABLET / ORALAB2019-04-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209243-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET / ORALAB2019-04-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209243-002DOXYCYCLINE HYCLATEEQ 150MG BASETABLET / ORALAB2019-04-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209243-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET / ORALAB2019-04-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209243-002DOXYCYCLINE HYCLATEEQ 150MG BASETABLET / ORALAB2019-04-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209243-001DOXYCYCLINE HYCLATEEQ 75MG BASETABLET / ORALAB2019-04-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209243-002DOXYCYCLINE HYCLATEEQ 150MG BASETABLET / ORALAB2019-04-1574a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209243-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209243-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209243-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209243-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209243-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209243-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209243-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209243-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209243-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209243-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209243-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209243-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209243-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209243-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209243-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209243-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209243-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209243-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209243-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209243-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209243-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209243-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209243-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209243-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209243-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209243-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209243-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209243-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209243-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209243-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209243-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209243-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209243-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209243-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209243-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209243-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209243-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A209243-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209243-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209243-002AB187673890dc5c…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4384-6EA - Each60505-43843b6062b2-bfed-4f85-8e17-9a207affbd5412019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-4384DOXYCYCLINE HYCLATE TABLET, COATED [APOTEX CORP.]6Legacy NDC20250412_2aa7ec9a-94b7-2f89-0d52-af9ec610b8fa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-4384-66050543840660 TABLET, COATED in 1 BOTTLE (60505-4384-6) 2019-08-010000-00-00NoNoCurrent