Minocycline Hydrochloride
- Product NDC
- 65862-885
- 11-digit product format
- 658620885
- Labeler code
- 65862
- Product ID
- 65862-885_5569f0f6-b36f-4149-aee7-2699fa5ebe53
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Minocycline Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA202261
- Marketing category
- ANDA
- Marketing start
- 2016-06-13
- Substance
- MINOCYCLINE HYDROCHLORIDE
- Active strength
- 105 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Minocycline Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MINOCYCLINE HYDROCHLORIDE | 105 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 0020414E5U |
| Rxcui | 629695, 629697, 629699, 858062, 858372, 1013659, 1013662, 1013665 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d9c90ddb-dcc8-42af-a94b-505e4488bdc7 | Product name | 1 | 20250623 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 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 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 23de08d7-aa4e-ec8b-ce6d-2124a855e4ef | Product name | 5 | 20180605 |
| 76736e48-254d-4a39-993d-206efbdaad1d | Product name | 1 | 20170717 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 0c498039-5512-d9d7-e6b6-833de47219ff | Product name | 2 | 20151106 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65862-885-01 | Minocycline Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | 10 | |
| 65862-885-05 | Minocycline Hydrochloride | 500 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 500 | 10 | |
| 65862-885-30 | Minocycline Hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | 10 | |
| 65862-885-99 | Minocycline Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 1000 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65862-885-30 | EA - Each | 65862-885 | f3e1ac55-691c-416b-aae3-cf57739fe5ad | 1 | 2019-12-10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1013659 | minocycline HCl 105 MG 24HR Extended Release Oral Tablet | PSN | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 858062 | minocycline HCl 115 MG 24HR Extended Release Oral Tablet | PSN | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 629695 | minocycline HCl 135 MG 24HR Extended Release Oral Tablet | PSN | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 629697 | minocycline HCl 45 MG 24HR Extended Release Oral Tablet | PSN | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 1013662 | minocycline HCl 55 MG 24HR Extended Release Oral Tablet | PSN | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 858372 | minocycline HCl 65 MG 24HR Extended Release Oral Tablet | PSN | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 1013665 | minocycline HCl 80 MG 24HR Extended Release Oral Tablet | PSN | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 629699 | minocycline HCl 90 MG 24HR Extended Release Oral Tablet | PSN | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 1013659 | 24 HR minocycline 105 MG Extended Release Oral Tablet | SCD | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 858062 | 24 HR minocycline 115 MG Extended Release Oral Tablet | SCD | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 629695 | 24 HR minocycline 135 MG Extended Release Oral Tablet | SCD | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 629697 | 24 HR minocycline 45 MG Extended Release Oral Tablet | SCD | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 1013662 | 24 HR minocycline 55 MG Extended Release Oral Tablet | SCD | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 858372 | 24 HR minocycline 65 MG Extended Release Oral Tablet | SCD | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 1013665 | 24 HR minocycline 80 MG Extended Release Oral Tablet | SCD | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 629699 | 24 HR minocycline 90 MG Extended Release Oral Tablet | SCD | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 1013659 | minocycline 105 MG (26.25 MG Immediate Release Beads / 78.75 MG Extended Release Beads) 24 HR Extended Release Oral Tablet | SY | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 1013659 | minocycline 105 MG (as minocycline HCl 113.4 MG) 24 HR Extended Release Oral Tablet | SY | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 1013659 | minocycline 105 MG 24 HR Extended Release Oral Tablet | SY | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 858062 | minocycline 115 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet | SY | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 858062 | minocycline 115 MG 24 HR Extended Release Oral Tablet | SY | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 629695 | minocycline 135 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet | SY | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 629695 | minocycline 135 MG 24 HR Extended Release Oral Tablet | SY | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 629697 | minocycline 45 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet | SY | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 629697 | minocycline 45 MG 24 HR Extended Release Oral Tablet | SY | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 1013662 | minocycline 55 MG 24 HR Extended Release Oral Tablet | SY | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 858372 | minocycline 65 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet | SY | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 858372 | minocycline 65 MG 24 HR Extended Release Oral Tablet | SY | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 1013665 | minocycline 80 MG 24 HR Extended Release Oral Tablet | SY | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 629699 | minocycline 90 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet | SY | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
| 629699 | minocycline 90 MG 24 HR Extended Release Oral Tablet | SY | e7b88a48-12b3-461d-b356-0d7ae4e8fd44 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 65862-885-01 | 65862088501 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-885-01) | 2016-06-13 | 0000-00-00 | No | No | Current |
| 65862-885-05 | 65862088505 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-885-05) | 2016-06-13 | 0000-00-00 | No | No | Current |
| 65862-885-30 | 65862088530 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-885-30) | 2016-06-13 | 0000-00-00 | No | No | Current |
| 65862-885-99 | 65862088599 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-885-99) | 2016-06-13 | 0000-00-00 | No | No | Current |