Minocycline Hydrochloride
- Product NDC
- 64380-154
- 11-digit product format
- 643800154
- Labeler code
- 64380
- Product ID
- 64380-154_73a30dc4-352b-4307-b902-07ffefc99a99
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Minocycline Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Strides Pharma Science Limited
- Application
- ANDA065131
- Marketing category
- ANDA
- Marketing start
- 2022-04-11
- Substance
- MINOCYCLINE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Tetracycline-class Drug [EPC], Tetracyclines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065131-001 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2003-04-16 | |
| A065131-002 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | AB | 2003-04-16 | |
| A065131-003 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | RS | 2003-04-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065131-001 | AB |
| A065131-002 | AB |
| A065131-003 | 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.
| 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 | A065131-001 | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2003-04-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065131-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | AB | 2003-04-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065131-003 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | RS | 2003-04-16 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065131-001 | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2003-04-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065131-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | AB | 2003-04-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065131-003 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | RS | 2003-04-16 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065131-001 | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2003-04-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065131-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | AB | 2003-04-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065131-003 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | RS | 2003-04-16 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065131-001 | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2003-04-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065131-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | AB | 2003-04-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065131-003 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | RS | 2003-04-16 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065131-001 | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2003-04-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065131-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | AB | 2003-04-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065131-003 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | RS | 2003-04-16 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065131-001 | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2003-04-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065131-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | AB | 2003-04-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065131-003 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | RS | 2003-04-16 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065131-001 | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2003-04-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065131-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | AB | 2003-04-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065131-003 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | RS | 2003-04-16 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065131-001 | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2003-04-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065131-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | AB | 2003-04-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065131-003 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | RS | 2003-04-16 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065131-001 | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2003-04-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065131-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | AB | 2003-04-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065131-003 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | RS | 2003-04-16 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065131-001 | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2003-04-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065131-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | AB | 2003-04-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065131-003 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | RS | 2003-04-16 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065131-001 | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2003-04-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065131-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | AB | 2003-04-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065131-003 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | RS | 2003-04-16 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065131-001 | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2003-04-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065131-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | AB | 2003-04-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065131-003 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | RS | 2003-04-16 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065131-001 | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2003-04-16 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065131-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | TABLET / ORAL | AB | 2003-04-16 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065131-003 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | TABLET / ORAL | AB | RS | 2003-04-16 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065131-001 | MINOCYCLINE HYDROCHLORIDE | EQ 50MG BASE | TABLET / ORAL | AB | 2003-04-16 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A065131-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065131-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065131-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065131-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065131-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065131-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065131-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065131-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065131-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065131-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065131-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065131-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065131-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065131-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065131-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065131-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065131-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065131-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065131-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065131-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065131-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065131-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065131-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065131-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065131-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065131-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065131-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065131-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065131-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065131-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065131-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065131-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065131-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065131-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065131-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065131-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065131-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065131-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065131-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065131-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Minocycline Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MINOCYCLINE HYDROCHLORIDE | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0020414E5U | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d6e136ba-c9b1-4846-ae2a-98a29cb4504d | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d9c90ddb-dcc8-42af-a94b-505e4488bdc7 | Product name | 1 | 20250623 |
| 9e423e97-a6d9-7bb0-0dcb-343af7c0ff92 | Product name | 2 | 20230322 |
| 472a6924-c7ed-850b-32ce-a510e887fbf9 | Product name | 4 | 20230207 |
| f1239550-2d2e-44c3-aec7-14fd9b4ab55d | Product name | 1 | 20201103 |
| 7a57513a-a145-4b95-9165-1e0ef21d6017 | Product name | 1 | 20200326 |
| 70555e58-6951-4421-9354-f80c6ce0d92c | Product name | 7 | 20200204 |
| 23de08d7-aa4e-ec8b-ce6d-2124a855e4ef | Product name | 5 | 20180605 |
| 76736e48-254d-4a39-993d-206efbdaad1d | Product name | 1 | 20170717 |
| 0c498039-5512-d9d7-e6b6-833de47219ff | Product name | 2 | 20151106 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64380-154-01 | Minocycline Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 64380-154-01 | EA - Each | 64380-154 | ca28d462-919d-48bf-b31e-e068ec0f7918 | 1 | 2022-06-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Strides Pharma Science Limited | d6e136ba-c9b1-4846-ae2a-98a29cb4504d | 2022-03-31 | Warnings, Adverse reactions | 065131 ANDA065131 64380-154 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 207364 | minocycline HCl 100 MG Oral Tablet | PSN | d6e136ba-c9b1-4846-ae2a-98a29cb4504d | 2 |
| 207362 | minocycline HCl 50 MG Oral Tablet | PSN | d6e136ba-c9b1-4846-ae2a-98a29cb4504d | 2 |
| 403840 | minocycline HCl 75 MG Oral Tablet | PSN | d6e136ba-c9b1-4846-ae2a-98a29cb4504d | 2 |
| 207364 | minocycline 100 MG Oral Tablet | SCD | d6e136ba-c9b1-4846-ae2a-98a29cb4504d | 2 |
| 207362 | minocycline 50 MG Oral Tablet | SCD | d6e136ba-c9b1-4846-ae2a-98a29cb4504d | 2 |
| 403840 | minocycline 75 MG Oral Tablet | SCD | d6e136ba-c9b1-4846-ae2a-98a29cb4504d | 2 |
| 207364 | minocycline (as minocycline hydrochloride) 100 MG Oral Tablet | SY | d6e136ba-c9b1-4846-ae2a-98a29cb4504d | 2 |
| 207362 | minocycline (as minocycline hydrochloride) 50 MG Oral Tablet | SY | d6e136ba-c9b1-4846-ae2a-98a29cb4504d | 2 |
| 403840 | minocycline (as minocycline hydrochloride) 75 MG Oral Tablet | SY | d6e136ba-c9b1-4846-ae2a-98a29cb4504d | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 64380-154-01 | 64380015401 | 100 TABLET in 1 BOTTLE (64380-154-01) | 100 tablet | 2022-04-11 | 0000-00-00 | No | No | Current |