Minocycline Hydrochloride
- Product NDC
- 63629-5327
- Requested package NDC
- 63629-5327-2
- 11-digit product format
- 636295327
- Labeler code
- 63629
- Product ID
- 63629-5327_6880f216-6721-42de-bb21-29a20acd6dde
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Minocycline Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA063065
- Marketing category
- ANDA
- Marketing start
- 1999-06-10
- 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
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.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63629-5327 | 63629-5327-2 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A063065-001 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1991-12-30 | |
| A063065-002 | MINOCYCLINE HYDROCHLORIDE | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1999-06-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A063065-001 | AB |
| A063065-002 | 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 | A063065-001 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1991-12-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A063065-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1999-06-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A063065-001 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1991-12-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A063065-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1999-06-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A063065-001 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1991-12-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A063065-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1999-06-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A063065-001 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1991-12-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A063065-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1999-06-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A063065-001 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1991-12-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A063065-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1999-06-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A063065-001 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1991-12-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A063065-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1999-06-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A063065-001 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1991-12-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A063065-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1999-06-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A063065-001 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1991-12-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A063065-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1999-06-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A063065-001 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1991-12-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A063065-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1999-06-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A063065-001 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1991-12-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A063065-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1999-06-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A063065-001 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1991-12-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A063065-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1999-06-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A063065-001 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1991-12-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A063065-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1999-06-10 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A063065-001 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1991-12-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A063065-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1999-06-10 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A063065-001 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1991-12-30 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A063065-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1999-06-10 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A063065-001 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1991-12-30 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A063065-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1999-06-10 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A063065-001 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1991-12-30 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A063065-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1999-06-10 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A063065-001 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1991-12-30 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A063065-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1999-06-10 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A063065-001 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1991-12-30 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A063065-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1999-06-10 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A063065-001 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1991-12-30 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A063065-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1999-06-10 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A063065-001 | MINOCYCLINE HYDROCHLORIDE | EQ 100MG BASE | CAPSULE / ORAL | AB | 1991-12-30 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A063065-002 | MINOCYCLINE HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | 1999-06-10 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A063065-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A063065-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A063065-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A063065-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A063065-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A063065-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A063065-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A063065-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A063065-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A063065-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A063065-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A063065-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A063065-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A063065-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A063065-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A063065-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A063065-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A063065-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A063065-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A063065-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A063065-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A063065-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A063065-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A063065-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A063065-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A063065-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A063065-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A063065-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A063065-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A063065-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A063065-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A063065-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A063065-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A063065-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A063065-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A063065-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A063065-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A063065-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A063065-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A063065-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Minocycline Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MINOCYCLINE HYDROCHLORIDE | 75 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0020414E5U | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 314108 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6f154720-706e-4177-8167-1bc893303f1b | 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 |
|---|---|---|---|---|---|---|
| 63629-5327-1 | Minocycline Hydrochloride | 30 in 1 BOTTLE | CAPSULE | 30 | 1003 | |
| 63629-5327-2 | Minocycline Hydrochloride | 60 in 1 BOTTLE | CAPSULE | 60 | 1003 | |
| 63629-5327-3 | Minocycline Hydrochloride | 16 in 1 BOTTLE | CAPSULE | 16 | 1003 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-5327 | MINOCYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK] | 1003 | Current NDC, 3 package rows | 20240906_6f154720-706e-4177-8167-1bc893303f1b.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 87a137c6-dd53-44d3-ab49-ef78ebed35c8 | 2026-06-12 | Warnings, Adverse reactions | 063065 ANDA063065 |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | REMEDYREPACK INC. | 6597bdc9-9e3a-4c11-8b39-27b47f863287 | 2026-02-04 | Warnings, Adverse reactions | 063065 ANDA063065 |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Actavis Pharma, Inc. | a5fc4d50-50b2-46e0-b722-4c6b2ec47d06 | 2025-06-30 | Warnings, Adverse reactions | 063065 ANDA063065 |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | 6f154720-706e-4177-8167-1bc893303f1b | 2024-09-04 | Warnings, Adverse reactions | 063065 ANDA063065 63629-5327-2 63629-5327 63629532702 |
| Minocycline Hydrochloride | MINOCYCLINE HYDROCHLORIDE | Bryant Ranch Prepack | a84c29a9-21a8-4965-b5a5-37b28e4af5a0 | 2019-06-13 | Warnings, Adverse reactions | 063065 ANDA063065 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 314108 | minocycline HCl 75 MG Oral Capsule | PSN | 6f154720-706e-4177-8167-1bc893303f1b | 1003 |
| 314108 | minocycline 75 MG Oral Capsule | SCD | 6f154720-706e-4177-8167-1bc893303f1b | 1003 |
| 314108 | minocycline (as minocycline hydrochloride) 75 MG Oral Capsule | SY | 6f154720-706e-4177-8167-1bc893303f1b | 1003 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63629-5327-2 | 63629532702 | 60 CAPSULE in 1 BOTTLE (63629-5327-2) | 60 capsule | 2014-05-02 | No | No | Current |