Minocycline Hydrochloride

Product NDC
68788-8097
Requested package NDC
68788-8097-3
11-digit product format
687888097
Labeler code
68788
Product ID
68788-8097_a968b555-9a24-4474-96e5-db97231b7da9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065470
Marketing category
ANDA
Marketing start
2021-10-06
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
2022-12-31
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 packagepackage68788-809768788-8097-3DDiscontinued 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065470-001MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-11
A065470-002MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-11
A065470-003MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065470-001AB
A065470-002AB
A065470-003AB

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 UTC2026-02A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065470-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2008-03-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065470-003MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB2008-03-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065470-001MINOCYCLINE HYDROCHLORIDEEQ 50MG BASECAPSULE / ORALAB2008-03-118072bd15b7f6…

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 UTC2026-02A065470-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065470-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065470-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065470-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065470-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065470-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065470-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065470-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065470-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065470-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065470-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065470-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065470-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065470-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065470-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065470-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065470-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065470-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065470-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065470-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065470-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065470-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065470-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065470-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065470-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065470-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065470-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065470-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065470-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065470-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065470-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065470-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065470-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065470-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065470-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065470-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065470-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065470-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065470-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065470-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8097-1EA - Each68788-809706172268-59aa-47e6-a9f4-51fd162170b112021-11-09
68788-8097-2EA - Each68788-809755f3c08e-2528-4a12-95e3-119e9c5ffeca12021-11-09
68788-8097-3EA - Each68788-80978e03d2f6-defd-4078-9e00-a748f302b62b12021-11-09
68788-8097-6EA - Each68788-8097964e46cf-dcd8-4e8d-8677-ce60665d328712021-11-09

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.caa99901-467c-4e99-b7e9-fbabdf5d118c2026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEREMEDYREPACK INC.0becbde8-6ec5-4830-a0d9-cfdb7b15eb842026-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepackbb3b9a7e-6724-4c2a-b3cb-236f522b31a82026-03-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEA-S Medication Solutionsc96b1c5d-7004-4ee2-ad48-0ba963389f862026-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDENorthwind Health Company, LLC12559b29-6568-4b99-a16e-6a87038981f72026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEAurobindo Pharma Limited9013ca48-15f2-43cd-a51d-91cf65c72a7c2025-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepackd00d9bc4-c764-4ec1-beb0-44668637bcfb2025-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepacka6224eeb-25be-4f1d-889f-809aaf338c8c2024-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.abaacdeb-2433-261a-e053-2995a90ae34e2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLC192327c5-d2bc-1bd1-e063-6394a90a110b2024-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEProficient Rx LP4f904969-5af3-461e-b557-d03a1e5c72922023-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065470
application number: ANDA065470

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8097-36878880970330 CAPSULE in 1 BOTTLE (68788-8097-3) 30 capsule2021-10-060000-00-00NoNoCurrent