Clindacin P
- Product NDC
- 43538-170
- Requested package NDC
- 43538-170-69
- 11-digit product format
- 435380170
- Labeler code
- 43538
- Product ID
- 43538-170_7401e200-c94b-43dc-813c-5ec521768e7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clindamycin phosphate
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Eurofarma, Inc.
- Application
- ANDA065049
- Marketing category
- ANDA
- Marketing start
- 2011-02-20
- Substance
- CLINDAMYCIN PHOSPHATE
- Active strength
- 10 mg/mL
- 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 |
|---|---|---|---|---|---|---|---|
| A065049-001 | CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065049-001 | AT |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | 2000-05-25 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | 2000-05-25 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | 2000-05-25 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | 2000-05-25 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | 2000-05-25 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | 2000-05-25 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | 2000-05-25 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A065049-001 | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SWAB / TOPICAL | AT | RS | 2000-05-25 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A065049-001 | AT | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A065049-001 | AT | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A065049-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065049-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065049-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065049-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065049-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065049-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065049-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065049-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065049-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065049-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065049-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065049-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065049-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065049-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065049-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065049-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065049-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065049-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065049-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065049-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065049-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A065049-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A065049-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A065049-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A065049-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A065049-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A065049-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A065049-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A065049-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A065049-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A065049-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065049-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065049-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065049-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A065049-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A065049-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065049-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A065049-001 | AT | 1 | f41ea6bd6efb… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clindacin P
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CLINDAMYCIN PHOSPHATE | 10 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| EH6D7113I8 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 309333 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 288371ef-96b6-4ce3-9be1-1d9d309b400c | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43538-170-69 | Clindacin P | 1 mL in 1 APPLICATOR | SOLUTION | 1 | 5 | |
| 43538-170-69 | Clindacin P | 69 in 1 JAR | SOLUTION | 69 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43538-170-69 | EA - Each | 43538-170 | 9c483554-e1c1-4b98-9d8e-94930e621e27 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43538-170 | CLINDACIN P (CLINDAMYCIN PHOSPHATE) SOLUTION CLINDACIN PAC (CLINDAMYCIN PHOSPHATE) SWAB [MEDIMETRIKS PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20231116_288371ef-96b6-4ce3-9be1-1d9d309b400c.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 |
|---|---|---|---|---|---|---|
| Clindacin P | CLINDAMYCIN PHOSPHATE | Eurofarma, Inc. | 288371ef-96b6-4ce3-9be1-1d9d309b400c | 2026-06-10 | Warnings, Adverse reactions | 065049 ANDA065049 43538-170-69 43538-170 43538017069 |
| Clindacin ETZ | CLINDAMYCIN PHOSPHATE | Eurofarma, Inc. | 89fed26e-1cad-4c0b-8695-d6f3562ba8d5 | 2026-04-02 | Warnings, Adverse reactions | 065049 ANDA065049 |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | Padagis Israel Pharmaceuticals Ltd | e492d645-7d2e-4f8a-a43a-9999456e9f72 | 2025-11-30 | Warnings, Adverse reactions | 065049 ANDA065049 |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | A-S Medication Solutions | 9cf27a58-6c5f-4a02-88cc-b5ce3ecd8751 | 2024-01-07 | Warnings, Adverse reactions | 065049 ANDA065049 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1091339 | Clindacin Pledget 1 % Medicated Pad | PSN | 288371ef-96b6-4ce3-9be1-1d9d309b400c | 5 |
| 797274 | clindamycin 1 % Medicated Pad | PSN | 288371ef-96b6-4ce3-9be1-1d9d309b400c | 5 |
| 309333 | clindamycin phosphate 1 % Topical Solution | PSN | 288371ef-96b6-4ce3-9be1-1d9d309b400c | 5 |
| 1091339 | clindamycin 10 MG/ML Medicated Pad [Clindacin] | SBD | 288371ef-96b6-4ce3-9be1-1d9d309b400c | 5 |
| 797274 | clindamycin 10 MG/ML Medicated Pad | SCD | 288371ef-96b6-4ce3-9be1-1d9d309b400c | 5 |
| 309333 | clindamycin 10 MG/ML Topical Solution | SCD | 288371ef-96b6-4ce3-9be1-1d9d309b400c | 5 |
| 1091339 | Clindacin 10 MG/ML Medicated Pad | SY | 288371ef-96b6-4ce3-9be1-1d9d309b400c | 5 |
| 1091339 | Clindacin ETZ (as clindamycin phosphate) 1 % Medicated Pad | SY | 288371ef-96b6-4ce3-9be1-1d9d309b400c | 5 |
| 1091339 | Clindacin P (as clindamycin phosphate) 1 % Medicated Pad | SY | 288371ef-96b6-4ce3-9be1-1d9d309b400c | 5 |
| 1091339 | Clindacin P 1 % Topical Swab | SY | 288371ef-96b6-4ce3-9be1-1d9d309b400c | 5 |
| 309333 | clindamycin (as clindamycin phosphate) 1 % Topical Solution | SY | 288371ef-96b6-4ce3-9be1-1d9d309b400c | 5 |
| 797274 | clindamycin (as clindamycin phosphate) 10 MG/ML Medicated Pad | SY | 288371ef-96b6-4ce3-9be1-1d9d309b400c | 5 |
| 797274 | clindamycin 1 % Medicated Pad | SY | 288371ef-96b6-4ce3-9be1-1d9d309b400c | 5 |
| 309333 | clindamycin 1 % Topical Solution | SY | 288371ef-96b6-4ce3-9be1-1d9d309b400c | 5 |
| 797274 | clindamycin 1 % Topical Swab | SY | 288371ef-96b6-4ce3-9be1-1d9d309b400c | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43538-170-69 | 43538017069 | 69 APPLICATOR in 1 JAR (43538-170-69) / 1 mL in 1 APPLICATOR | 69 applicator | 2026-06-15 | 0000-00-00 | No | No | Current |