clindamycin hydrochloride
- Product NDC
- 59762-5010
- Requested package NDC
- 59762-5010-1
- 11-digit product format
- 597625010
- Labeler code
- 59762
- Product ID
- 59762-5010_b0325c66-cf49-4a6b-a333-06e53515832b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clindamycin hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- NDA050162
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 1970-05-22
- Marketing end
- 2026-06-30
- 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
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 59762-5010 | 59762-5010-1 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050162-001 | CLEOCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | |
| N050162-002 | CLEOCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | |
| N050162-003 | CLEOCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | RLD, RS | 1988-04-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N050162-001 | AB |
| N050162-002 | AB |
| N050162-003 | 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 | N050162-001 | CLEOCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050162-002 | CLEOCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050162-003 | CLEOCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | RLD, RS | 1988-04-14 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050162-001 | CLEOCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050162-002 | CLEOCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050162-003 | CLEOCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | RLD, RS | 1988-04-14 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050162-001 | CLEOCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050162-002 | CLEOCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050162-003 | CLEOCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | RLD, RS | 1988-04-14 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050162-001 | CLEOCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050162-002 | CLEOCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050162-003 | CLEOCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | RLD, RS | 1988-04-14 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050162-001 | CLEOCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050162-002 | CLEOCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050162-003 | CLEOCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | RLD, RS | 1988-04-14 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050162-001 | CLEOCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050162-002 | CLEOCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050162-003 | CLEOCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | RLD, RS | 1988-04-14 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050162-001 | CLEOCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050162-002 | CLEOCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050162-003 | CLEOCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | RLD, RS | 1988-04-14 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050162-001 | CLEOCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050162-002 | CLEOCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050162-003 | CLEOCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | RLD, RS | 1988-04-14 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050162-001 | CLEOCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050162-002 | CLEOCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050162-003 | CLEOCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | RLD, RS | 1988-04-14 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050162-001 | CLEOCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050162-002 | CLEOCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050162-003 | CLEOCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | RLD, RS | 1988-04-14 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050162-001 | CLEOCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050162-002 | CLEOCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050162-003 | CLEOCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | RLD, RS | 1988-04-14 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050162-001 | CLEOCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050162-002 | CLEOCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050162-003 | CLEOCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | RLD, RS | 1988-04-14 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050162-001 | CLEOCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050162-002 | CLEOCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050162-003 | CLEOCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | RLD, RS | 1988-04-14 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050162-001 | CLEOCIN HYDROCHLORIDE | EQ 75MG BASE | CAPSULE / ORAL | AB | RLD, Approved before 1982 | 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 | N050162-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050162-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N050162-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050162-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050162-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050162-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050162-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N050162-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N050162-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050162-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050162-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050162-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050162-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050162-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050162-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050162-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050162-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050162-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050162-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050162-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050162-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050162-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050162-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050162-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050162-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050162-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050162-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050162-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N050162-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N050162-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050162-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050162-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050162-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050162-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050162-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050162-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050162-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050162-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050162-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050162-001 | AB | 1 | 8072bd15b7f6… |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59762-5010-1 | clindamycin hydrochloride | 16 in 1 BOTTLE | CAPSULE | 16 | 35 | |
| 59762-5010-2 | clindamycin hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | 35 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59762-5010-1 | EA - Each | 59762-5010 | 815ea5e9-1c15-4b15-8187-bcade7cae6dd | 1 | 2012-07-24 |
| 59762-5010-2 | EA - Each | 59762-5010 | 1b2c2384-7ceb-4c5d-80df-98576d19fd90 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59762-5010 | CLINDAMYCIN HYDROCHLORIDE CAPSULE [MYLAN PHARMACEUTICALS INC.] | 32 | Current NDC, Legacy NDC, 2 package rows | 20250529_24595bb3-07ea-4d5f-9bb3-2c2332a1fc62.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 |
|---|---|---|---|---|---|---|
| clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Mylan Pharmaceuticals Inc. | 24595bb3-07ea-4d5f-9bb3-2c2332a1fc62 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | 050162 NDA050162 59762-5010-1 59762-5010 59762501001 |
| Cleocin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Pharmacia & Upjohn Company LLC | df9a2a41-b132-4f43-8940-b2d773b1369a | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | 050162 NDA050162 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197518 | clindamycin HCl 150 MG Oral Capsule | PSN | 24595bb3-07ea-4d5f-9bb3-2c2332a1fc62 | 35 |
| 284215 | clindamycin HCl 300 MG Oral Capsule | PSN | 24595bb3-07ea-4d5f-9bb3-2c2332a1fc62 | 35 |
| 197518 | clindamycin 150 MG Oral Capsule | SCD | 24595bb3-07ea-4d5f-9bb3-2c2332a1fc62 | 35 |
| 284215 | clindamycin 300 MG Oral Capsule | SCD | 24595bb3-07ea-4d5f-9bb3-2c2332a1fc62 | 35 |
| 197518 | clindamycin (as clindamycin HCl) 150 MG Oral Capsule | SY | 24595bb3-07ea-4d5f-9bb3-2c2332a1fc62 | 35 |
| 284215 | clindamycin (as clindamycin HCl) 300 MG Oral Capsule | SY | 24595bb3-07ea-4d5f-9bb3-2c2332a1fc62 | 35 |
| 284215 | clindamycin HCl 300 MG Oral Capsule | PSN | 1ad83cad-b1ed-bab9-e063-6394a90abc8a | 1 |
| 284215 | clindamycin 300 MG Oral Capsule | SCD | 1ad83cad-b1ed-bab9-e063-6394a90abc8a | 1 |
| 284215 | clindamycin (as clindamycin HCl) 300 MG Oral Capsule | SY | 1ad83cad-b1ed-bab9-e063-6394a90abc8a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59762-5010-1 | 59762501001 | 16 CAPSULE in 1 BOTTLE (59762-5010-1) | 16 capsule | 1970-05-22 | 0000-00-00 | No | No | Current |