Home NDC 0591-5694 Minocycline Hydrochloride
Product NDC 0591-5694
11-digit product format 005915694
Labeler code 0591
Product ID 0591-5694_2d74faa2-99c4-4f01-adc6-60110d2b24da
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Minocycline Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA063181
Marketing category ANDA
Marketing start 1992-02-01
Substance MINOCYCLINE HYDROCHLORIDE
Active strength 50 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 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 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 0591-5694-00 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 0591-5694-00 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 0591-5694-00 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 0591-5694-00 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 0591-5694-00 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 0591-5694-00 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 0591-5694-00 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 0591-5694-00 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 0591-5694-00 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 0591-5694-00 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 0591-5694-00 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 0591-5694-00 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 0591-5694-00 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 0591-5694-00 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 unfinished product product 906f6e251498…bf70b80e44f0…2022-04-09 23:13 UTC · source 2022-04-08 unfinished package package 0591-5694-00 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 unfinished product product 6db9cb8d1e19…3449e1ec5b70…2021-12-27 23:28 UTC · source 2021-12-27 unfinished package package 0591-5694-00 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 unfinished product product 8fc7167e32ce…e96bbc724034…2021-02-18 23:40 UTC · source 2021-02-18 unfinished package package 0591-5694-00 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 unfinished product product 4184dd79f89f…545327b3e20f…2020-12-18 03:04 UTC · source 2020-12-17 unfinished package package 0591-5694-00 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished product product 4bd3596a7b87…5c64c6f6865f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished package package 0591-5694-00 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 unfinished product product 263afe128892…91768de4ddbe…2019-12-08 06:16 UTC · source 2019-12-05 unfinished package package 0591-5694-00 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 unfinished product product 5b2001dcd8f5…54b53d4dc9e4…2019-06-01 22:24 UTC · source 2019-05-30 unfinished package package 0591-5694-00 5b2001dcd8f5…54b53d4dc9e4…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A063181-001 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A063181-001 AB
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 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A063181-001 MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 1991-12-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product No
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINOCYCLINE HYDROCHLORIDE 50 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0591-5694-01 Minocycline Hydrochloride 100 in 1 BOTTLE, PLASTIC CAPSULE 100 23 0591-5694-60 Minocycline Hydrochloride 60 in 1 BOTTLE, PLASTIC CAPSULE 60 23
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MINOCYCLINE HYDROCHLORIDE ACTIVE INGREDIENT 0020414E5U MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.] 15 MINOCYCLINE ACTIVE MOIETY FYY3R43WGO MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.] 15 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.] 15 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.] 15 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.] 15 GELATIN INACTIVE INGREDIENT 2G86QN327L MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.] 15 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.] 15 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.] 15 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.] 15 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.] 15 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.] 15 MINOCYCLINE HYDROCHLORIDE ACTIVE INGREDIENT 0020414E5U MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 10 MINOCYCLINE ACTIVE MOIETY FYY3R43WGO MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 10 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 10 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 10 GELATIN INACTIVE INGREDIENT 2G86QN327L MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 10 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 10 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 10 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MINOCYCLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-5694 MINOCYCLINE HYDROCHLORIDE CAPSULE [ACTAVIS PHARMA, INC.] 21 Current NDC, Legacy NDC, 2 package rows 20241006_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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0591-5694-00 00591569400 37310 CAPSULE in 1 BOX (0591-5694-00) 37310 capsule 30-DEC-91 Current 0591-5694-01 00591569401 100 CAPSULE in 1 BOTTLE, PLASTIC (0591-5694-01) 100 capsule 1992-02-01 0000-00-00 No No Current 0591-5694-60 00591569460 60 CAPSULE in 1 BOTTLE, PLASTIC (0591-5694-60) 60 capsule 2006-05-25 0000-00-00 No No Current