Minocycline Hydrochloride

Product NDC
0591-3153
Requested package NDC
0591-3153-00
11-digit product format
005913153
Labeler code
0591
Product ID
0591-3153_2d74faa2-99c4-4f01-adc6-60110d2b24da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Minocycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA063065
Marketing category
ANDA
Marketing start
2002-09-17
Marketing end
2026-07-31
Substance
MINOCYCLINE HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
unfinished packagepackage0591-31530591-3153-00UNFINISHEDActive or certified unfinished drug listing2026-08-12

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 · 21 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 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-276db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-188fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-174184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-104bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-305b2001dcd8f5…54b53d4dc9e4…

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
A063065-001MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-30
A063065-002MINOCYCLINE HYDROCHLORIDEMINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A063065-001AB
A063065-002AB

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 UTC2026-02A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A063065-001MINOCYCLINE HYDROCHLORIDEEQ 100MG BASECAPSULE / ORALAB1991-12-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A063065-002MINOCYCLINE HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB1999-06-10782e0a99824c…

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 UTC2026-02A063065-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A063065-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063065-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A063065-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A063065-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A063065-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063065-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A063065-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063065-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A063065-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063065-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A063065-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063065-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A063065-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063065-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A063065-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063065-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A063065-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A063065-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A063065-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063065-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A063065-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A063065-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A063065-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A063065-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A063065-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A063065-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A063065-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063065-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A063065-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A063065-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A063065-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A063065-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A063065-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A063065-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A063065-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A063065-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A063065-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A063065-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A063065-002AB1782e0a99824c…

Additional Listing Data#

Finished product
No
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINOCYCLINE HYDROCHLORIDE75 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9c90ddb-dcc8-42af-a94b-505e4488bdc7Product name120250623
9e423e97-a6d9-7bb0-0dcb-343af7c0ff92Product name220230322
472a6924-c7ed-850b-32ce-a510e887fbf9Product name420230207
f1239550-2d2e-44c3-aec7-14fd9b4ab55dProduct name120201103
7a57513a-a145-4b95-9165-1e0ef21d6017Product name120200326
70555e58-6951-4421-9354-f80c6ce0d92cProduct name720200204
23de08d7-aa4e-ec8b-ce6d-2124a855e4efProduct name520180605
76736e48-254d-4a39-993d-206efbdaad1dProduct name120170717
0c498039-5512-d9d7-e6b6-833de47219ffProduct name220151106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-3153-01Minocycline Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE10023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3153-01EA - Each0591-315364ba3cb9-ceeb-4ce2-887f-fc8c20b73f5812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000
GELATININACTIVE INGREDIENT2G86QN327LMINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1000
MINOCYCLINE HYDROCHLORIDEACTIVE INGREDIENT0020414E5UMINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15
MINOCYCLINEACTIVE MOIETYFYY3R43WGOMINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHMINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GMINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15
GELATININACTIVE INGREDIENT2G86QN327LMINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3153MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.]21Current NDC, Legacy NDC, 1 package rows20241006_a5fc4d50-50b2-46e0-b722-4c6b2ec47d06.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.87a137c6-dd53-44d3-ab49-ef78ebed35c82026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 063065
application number: ANDA063065
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEREMEDYREPACK INC.6597bdc9-9e3a-4c11-8b39-27b47f8632872026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 063065
application number: ANDA063065
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEActavis Pharma, Inc.a5fc4d50-50b2-46e0-b722-4c6b2ec47d062025-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 063065
application number: ANDA063065
ndc (product): 0591-3153
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepack6f154720-706e-4177-8167-1bc893303f1b2024-09-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 063065
application number: ANDA063065
Minocycline HydrochlorideMINOCYCLINE HYDROCHLORIDEBryant Ranch Prepacka84c29a9-21a8-4965-b5a5-37b28e4af5a02019-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 063065
application number: ANDA063065

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314108minocycline HCl 75 MG Oral CapsulePSN6f154720-706e-4177-8167-1bc893303f1b1003
314108minocycline 75 MG Oral CapsuleSCD6f154720-706e-4177-8167-1bc893303f1b1003
314108minocycline (as minocycline hydrochloride) 75 MG Oral CapsuleSY6f154720-706e-4177-8167-1bc893303f1b1003
197984minocycline HCl 100 MG Oral CapsulePSNa5fc4d50-50b2-46e0-b722-4c6b2ec47d0623
197985minocycline HCl 50 MG Oral CapsulePSNa5fc4d50-50b2-46e0-b722-4c6b2ec47d0623
314108minocycline HCl 75 MG Oral CapsulePSNa5fc4d50-50b2-46e0-b722-4c6b2ec47d0623
197984minocycline 100 MG Oral CapsuleSCDa5fc4d50-50b2-46e0-b722-4c6b2ec47d0623
197985minocycline 50 MG Oral CapsuleSCDa5fc4d50-50b2-46e0-b722-4c6b2ec47d0623
314108minocycline 75 MG Oral CapsuleSCDa5fc4d50-50b2-46e0-b722-4c6b2ec47d0623
197984minocycline (as minocycline HCl) 100 MG Oral CapsuleSYa5fc4d50-50b2-46e0-b722-4c6b2ec47d0623
197985minocycline (as minocycline HCl) 50 MG Oral CapsuleSYa5fc4d50-50b2-46e0-b722-4c6b2ec47d0623
314108minocycline (as minocycline hydrochloride) 75 MG Oral CapsuleSYa5fc4d50-50b2-46e0-b722-4c6b2ec47d0623

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
0591-3153-000059131530039840 CAPSULE in 1 BOX (0591-3153-00)39840 capsule10-JUN-99Current