Minocycline

Product NDC
49884-513
11-digit product format
498840513
Labeler code
49884
Product ID
49884-513_6b95ec55-8686-495a-b24c-4e4409a5c2e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline
Dosage form
TABLET
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA065131
Marketing category
ANDA
Marketing start
2003-04-16
Marketing end
0000-00-00
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49884-513DDiscontinued by firm2026-08-11
excluded packagepackage49884-51349884-513-03DDiscontinued 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 · 18 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 packagepackage49884-513-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49884-513-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49884-513-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49884-513-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49884-513-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49884-513-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49884-513-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49884-513-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49884-513-030efc9e666f02…f202fb6c5f17…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065131-001MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2003-04-16
A065131-002MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2003-04-16
A065131-003MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALABRS2003-04-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A065131-001AB
A065131-002AB
A065131-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065131-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2003-04-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065131-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2003-04-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065131-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALABRS2003-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065131-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2003-04-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065131-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2003-04-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065131-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALABRS2003-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A065131-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2003-04-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065131-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2003-04-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065131-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALABRS2003-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065131-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2003-04-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065131-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2003-04-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065131-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALABRS2003-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065131-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2003-04-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065131-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2003-04-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065131-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALABRS2003-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065131-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2003-04-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065131-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2003-04-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065131-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALABRS2003-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065131-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2003-04-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065131-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2003-04-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065131-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALABRS2003-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065131-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2003-04-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065131-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2003-04-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065131-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALABRS2003-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065131-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2003-04-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065131-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2003-04-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065131-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALABRS2003-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065131-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2003-04-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A065131-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2003-04-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A065131-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALABRS2003-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065131-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2003-04-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065131-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2003-04-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065131-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALABRS2003-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065131-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2003-04-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065131-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2003-04-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065131-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALABRS2003-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065131-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2003-04-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065131-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2003-04-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065131-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALABRS2003-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065131-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2003-04-168072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065131-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065131-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065131-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065131-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065131-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065131-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065131-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065131-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065131-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065131-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065131-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065131-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065131-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065131-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065131-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065131-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065131-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065131-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065131-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065131-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065131-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065131-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065131-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065131-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065131-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065131-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065131-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065131-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065131-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065131-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065131-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065131-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065131-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065131-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065131-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065131-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065131-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065131-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065131-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065131-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-513-03EA - Each49884-513905b52e4-f8be-466b-b8d6-ade8c915eed012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.]3
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.]3
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQMINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE (MINOCYCLINE) TABLET [PAR PHARMACEUTICAL, INC.]3

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 HYDROCHLORIDEStrides Pharma Science Limitedd6e136ba-c9b1-4846-ae2a-98a29cb4504d2022-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065131
application number: ANDA065131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-513-034988405130350 TABLET in 1 BOTTLE (49884-513-03) 50 tablet2003-04-162024-04-30NoNoCurrent