Home NDC 68382-317 Minocycline hydrochloride
Product NDC 68382-317
11-digit product format 683820317
Labeler code 68382
Product ID 68382-317_0c236c6b-5f2a-4b46-a12f-45c47b90b65a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Minocycline hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA063009
Marketing category ANDA
Marketing start 2017-04-03
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A063009-001 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RS 1992-03-02 A063009-002 MINOCYCLINE HYDROCHLORIDE MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2003-08-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A063009-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RS 1992-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A063009-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2003-08-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A063009-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RS 1992-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A063009-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2003-08-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A063009-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RS 1992-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A063009-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2003-08-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A063009-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RS 1992-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A063009-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2003-08-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A063009-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RS 1992-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A063009-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2003-08-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A063009-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RS 1992-03-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A063009-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2003-08-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A063009-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RS 1992-03-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A063009-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2003-08-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A063009-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RS 1992-03-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A063009-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2003-08-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A063009-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RS 1992-03-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A063009-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2003-08-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A063009-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RS 1992-03-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A063009-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2003-08-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A063009-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RS 1992-03-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A063009-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2003-08-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A063009-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RS 1992-03-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A063009-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2003-08-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A063009-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RS 1992-03-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A063009-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2003-08-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A063009-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RS 1992-03-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A063009-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2003-08-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A063009-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RS 1992-03-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A063009-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2003-08-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A063009-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RS 1992-03-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A063009-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2003-08-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A063009-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RS 1992-03-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A063009-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2003-08-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A063009-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RS 1992-03-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A063009-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2003-08-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A063009-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RS 1992-03-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A063009-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2003-08-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A063009-001 MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE CAPSULE / ORAL AB RS 1992-03-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A063009-002 MINOCYCLINE HYDROCHLORIDE EQ 75MG BASE CAPSULE / ORAL AB 2003-08-12 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Minocycline hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINOCYCLINE HYDROCHLORIDE 75 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0020414E5U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197984 Internal RxNorm lookup 197985 Internal RxNorm lookup 314108 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68382-317-01 Minocycline hydrochloride 100 in 1 BOTTLE CAPSULE 100 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-317 MINOCYCLINE HYDROCHLORIDE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.] 7 Current NDC, Legacy NDC, 1 package rows 20250427_25acb785-6838-4e62-9e86-ddc30b2b759a.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 · 3 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 68382-317-01 68382031701 100 CAPSULE in 1 BOTTLE (68382-317-01) 100 capsule 2017-04-03 0000-00-00 No No Current