Clindamycin Hydrochloride
- Product NDC
- 51655-317
- 11-digit product format
- 516550317
- Labeler code
- 51655
- Product ID
- 51655-317_48eafee0-659a-6204-e063-6394a90a69e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clindamycin Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA065442
- Marketing category
- ANDA
- Marketing start
- 2022-11-28
- Substance
- CLINDAMYCIN HYDROCHLORIDE
- Active strength
- 300 mg/1
- Pharmacologic classes
- Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065442-001 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | |
| A065442-002 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2009-08-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065442-001 | AB |
| A065442-002 | 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 | A065442-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065442-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065442-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065442-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065442-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065442-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065442-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065442-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065442-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065442-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065442-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065442-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065442-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065442-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065442-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065442-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065442-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065442-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065442-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065442-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065442-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065442-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065442-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065442-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065442-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065442-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065442-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065442-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065442-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065442-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065442-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065442-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065442-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065442-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065442-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065442-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065442-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065442-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A065442-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A065442-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2009-08-26 | 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 | A065442-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A065442-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065442-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065442-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065442-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A065442-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065442-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065442-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065442-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065442-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065442-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065442-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065442-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065442-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065442-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065442-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065442-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065442-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065442-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A065442-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065442-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065442-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065442-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065442-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065442-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065442-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065442-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A065442-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065442-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065442-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065442-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A065442-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065442-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065442-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065442-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065442-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065442-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065442-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065442-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A065442-002 | AB | 1 | 782e0a99824c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clindamycin Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CLINDAMYCIN HYDROCHLORIDE | 300 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| T20OQ1YN1W | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 284215 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f2f08e98-f6c5-7c2d-e053-2995a90abe1e | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51655-317-51 | Clindamycin Hydrochloride | 40 in 1 BOTTLE, PLASTIC | CAPSULE | 40 | 4 | |
| 51655-317-52 | Clindamycin Hydrochloride | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | 4 |
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 |
|---|---|---|---|---|---|---|
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Major Pharmaceuticals | d53a66bf-fdbd-4a12-8d8c-4e3ab94e9ef5 | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 065442 ANDA065442 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Aurobindo Pharma Limited | 2367340c-d297-4a3f-8253-6d27a0ed39cb | 2026-04-01 | Boxed warning, Warnings, Adverse reactions | 065442 ANDA065442 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Northwind Health Company, LLC | f2f08e98-f6c5-7c2d-e053-2995a90abe1e | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 065442 ANDA065442 51655-317 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Redpharm Drug | 0a0fbeae-2bc2-2402-e063-6394a90a97a0 | 2025-12-25 | Boxed warning, Warnings, Adverse reactions | 065442 ANDA065442 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | VERITYRX, LLC | 427a0138-c2dd-cf0b-e063-6394a90af407 | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | 065442 ANDA065442 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | A-S Medication Solutions | 9fe68a5a-487b-4119-9ee7-603948d732e4 | 2025-09-23 | Boxed warning, Warnings, Adverse reactions | 065442 ANDA065442 |
| Clindamycin HCL | CLINDAMYCIN HCL | Advanced Rx Pharmacy of Tennessee, LLC | c46cac0a-0c36-02fa-e053-2995a90a772b | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 065442 ANDA065442 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | A-S Medication Solutions | 8af1493c-1f22-4629-a432-f8b0578189e1 | 2024-09-04 | Boxed warning, Warnings, Adverse reactions | 065442 ANDA065442 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | A-S Medication Solutions | 2393251d-33b9-4274-9d04-27ec9968eaa1 | 2024-05-20 | Boxed warning, Warnings, Adverse reactions | 065442 ANDA065442 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Proficient Rx LP | d6e1a5f2-9dcb-49fb-a5b0-d7d543520ac3 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 065442 ANDA065442 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 284215 | clindamycin HCl 300 MG Oral Capsule | PSN | f2f08e98-f6c5-7c2d-e053-2995a90abe1e | 4 |
| 284215 | clindamycin 300 MG Oral Capsule | SCD | f2f08e98-f6c5-7c2d-e053-2995a90abe1e | 4 |
| 284215 | clindamycin (as clindamycin HCl) 300 MG Oral Capsule | SY | f2f08e98-f6c5-7c2d-e053-2995a90abe1e | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 51655-317-51 | 51655031751 | 40 CAPSULE in 1 BOTTLE, PLASTIC (51655-317-51) | 40 capsule | 2022-11-28 | No | No | Current |
| 51655-317-52 | 51655031752 | 30 CAPSULE in 1 BOTTLE, PLASTIC (51655-317-52) | 30 capsule | 2023-03-10 | No | No | Current |