Minocycline Hydrochloride

Product NDC
16714-109
Requested package NDC
16714-109-01
11-digit product format
167140109
Labeler code
16714
Product ID
16714-109_eba34835-21e0-44ef-838f-ab2b94fda592
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA202261
Marketing category
ANDA
Marketing start
2012-11-19
Marketing end
0000-00-00
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
135 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC],Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage16714-10916714-109-01DDiscontinued by firm2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202261-001MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 45MG BASETABLET, EXTENDED RELEASE / ORALAB2012-11-19
A202261-002MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 65MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-28
A202261-003MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 90MG BASETABLET, EXTENDED RELEASE / ORALAB2012-11-19
A202261-004MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 115MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-28
A202261-005MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 135MG BASETABLET, EXTENDED RELEASE / ORALAB2012-11-19
A202261-006MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 80MG BASETABLET, EXTENDED RELEASE / ORALAB2016-06-13
A202261-007MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 105MG BASETABLET, EXTENDED RELEASE / ORALAB2016-06-13
A202261-008MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 55MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-productTE code
A202261-001AB
A202261-002AB
A202261-003AB
A202261-004AB
A202261-005AB
A202261-006AB
A202261-007AB
A202261-008AB

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 9 · 327 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202261-001MINOCYCLINE HYDROCHLORIDEEQ 45MG BASETABLET, EXTENDED RELEASE / ORALAB2012-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202261-002MINOCYCLINE HYDROCHLORIDEEQ 65MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202261-003MINOCYCLINE HYDROCHLORIDEEQ 90MG BASETABLET, EXTENDED RELEASE / ORALAB2012-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202261-004MINOCYCLINE HYDROCHLORIDEEQ 115MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202261-005MINOCYCLINE HYDROCHLORIDEEQ 135MG BASETABLET, EXTENDED RELEASE / ORALAB2012-11-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202261-006MINOCYCLINE HYDROCHLORIDEEQ 80MG BASETABLET, EXTENDED RELEASE / ORALAB2016-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202261-007MINOCYCLINE HYDROCHLORIDEEQ 105MG BASETABLET, EXTENDED RELEASE / ORALAB2016-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202261-008MINOCYCLINE HYDROCHLORIDEEQ 55MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202261-001MINOCYCLINE HYDROCHLORIDEEQ 45MG BASETABLET, EXTENDED RELEASE / ORALAB2012-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202261-002MINOCYCLINE HYDROCHLORIDEEQ 65MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202261-003MINOCYCLINE HYDROCHLORIDEEQ 90MG BASETABLET, EXTENDED RELEASE / ORALAB2012-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202261-004MINOCYCLINE HYDROCHLORIDEEQ 115MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202261-005MINOCYCLINE HYDROCHLORIDEEQ 135MG BASETABLET, EXTENDED RELEASE / ORALAB2012-11-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202261-006MINOCYCLINE HYDROCHLORIDEEQ 80MG BASETABLET, EXTENDED RELEASE / ORALAB2016-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202261-007MINOCYCLINE HYDROCHLORIDEEQ 105MG BASETABLET, EXTENDED RELEASE / ORALAB2016-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202261-008MINOCYCLINE HYDROCHLORIDEEQ 55MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202261-001MINOCYCLINE HYDROCHLORIDEEQ 45MG BASETABLET, EXTENDED RELEASE / ORALAB2012-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202261-002MINOCYCLINE HYDROCHLORIDEEQ 65MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202261-003MINOCYCLINE HYDROCHLORIDEEQ 90MG BASETABLET, EXTENDED RELEASE / ORALAB2012-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202261-004MINOCYCLINE HYDROCHLORIDEEQ 115MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202261-005MINOCYCLINE HYDROCHLORIDEEQ 135MG BASETABLET, EXTENDED RELEASE / ORALAB2012-11-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202261-006MINOCYCLINE HYDROCHLORIDEEQ 80MG BASETABLET, EXTENDED RELEASE / ORALAB2016-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202261-007MINOCYCLINE HYDROCHLORIDEEQ 105MG BASETABLET, EXTENDED RELEASE / ORALAB2016-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202261-008MINOCYCLINE HYDROCHLORIDEEQ 55MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202261-001MINOCYCLINE HYDROCHLORIDEEQ 45MG BASETABLET, EXTENDED RELEASE / ORALAB2012-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202261-002MINOCYCLINE HYDROCHLORIDEEQ 65MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202261-003MINOCYCLINE HYDROCHLORIDEEQ 90MG BASETABLET, EXTENDED RELEASE / ORALAB2012-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202261-004MINOCYCLINE HYDROCHLORIDEEQ 115MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202261-005MINOCYCLINE HYDROCHLORIDEEQ 135MG BASETABLET, EXTENDED RELEASE / ORALAB2012-11-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202261-006MINOCYCLINE HYDROCHLORIDEEQ 80MG BASETABLET, EXTENDED RELEASE / ORALAB2016-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202261-007MINOCYCLINE HYDROCHLORIDEEQ 105MG BASETABLET, EXTENDED RELEASE / ORALAB2016-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202261-008MINOCYCLINE HYDROCHLORIDEEQ 55MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202261-001MINOCYCLINE HYDROCHLORIDEEQ 45MG BASETABLET, EXTENDED RELEASE / ORALAB2012-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202261-002MINOCYCLINE HYDROCHLORIDEEQ 65MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202261-003MINOCYCLINE HYDROCHLORIDEEQ 90MG BASETABLET, EXTENDED RELEASE / ORALAB2012-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202261-004MINOCYCLINE HYDROCHLORIDEEQ 115MG BASETABLET, EXTENDED RELEASE / ORALAB2018-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202261-005MINOCYCLINE HYDROCHLORIDEEQ 135MG BASETABLET, EXTENDED RELEASE / ORALAB2012-11-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202261-006MINOCYCLINE HYDROCHLORIDEEQ 80MG BASETABLET, EXTENDED RELEASE / ORALAB2016-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202261-007MINOCYCLINE HYDROCHLORIDEEQ 105MG BASETABLET, EXTENDED RELEASE / ORALAB2016-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202261-008MINOCYCLINE HYDROCHLORIDEEQ 55MG BASETABLET, EXTENDED RELEASE / ORALAB2019-08-21b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 327 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202261-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202261-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202261-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202261-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202261-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202261-006AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202261-007AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202261-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202261-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202261-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202261-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202261-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202261-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202261-006AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202261-007AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202261-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202261-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202261-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202261-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202261-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202261-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202261-006AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202261-007AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202261-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202261-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202261-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202261-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202261-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202261-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202261-006AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202261-007AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202261-008AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202261-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202261-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202261-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202261-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202261-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202261-006AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202261-007AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202261-008AB1b8a1b40f171c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-109-01EA - Each16714-10980ed06e1-6864-47a3-938d-6d69d0915f8212019-12-10

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEAurobindo Pharma Limitede7b88a48-12b3-461d-b356-0d7ae4e8fd442025-04-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202261
application number: ANDA202261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-109-011671401090130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16714-109-01) 2012-11-190000-00-00NoNoCurrent