CLINDAMYCIN PALMITATE HYDROCHLORIDE

Product NDC
63629-2391
11-digit product format
636292391
Labeler code
63629
Product ID
63629-2391_9fa1fe7d-c938-41cc-a2a7-5be0fa4dbc35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLINDAMYCIN PALMITATE HYDROCHLORIDE
Dosage form
GRANULE, FOR SOLUTION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201821
Marketing category
ANDA
Marketing start
2012-09-11
Substance
CLINDAMYCIN PALMITATE HYDROCHLORIDE
Active strength
75 mg/5mL
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDECLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A201821-001AA

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-283f01610625f2…
2019-09-15 20:21 UTC2019-09A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201821-001CLINDAMYCIN PALMITATE HYDROCHLORIDEEQ 75MG BASE/5MLFOR SOLUTION / ORALAA2012-08-28cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201821-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201821-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201821-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201821-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201821-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201821-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201821-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201821-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201821-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201821-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201821-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201821-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201821-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201821-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201821-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201821-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201821-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201821-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201821-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201821-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201821-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A201821-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201821-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201821-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201821-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A201821-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201821-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201821-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201821-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201821-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201821-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201821-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201821-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201821-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A201821-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A201821-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201821-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201821-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201821-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201821-001AA1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
CLINDAMYCIN PALMITATE HYDROCHLORIDE
Brand name suffix
(Pediatric)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLINDAMYCIN PALMITATE HYDROCHLORIDE75 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VN9A8JM7M7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
562266Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3afe52c2-b65b-40fe-b2fa-da39f1bcf529Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
1426d8f8-b7d5-4053-8554-613df00c0d86Product name220250616
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d8f81258-db12-0761-46cc-8ff6e62e9302Product name420240422
b7b2fa42-1c77-d724-81f0-87da60a77e79Product name320240320
b27c7c65-51f2-a62f-e0e6-a26b3a0f8eb0Product name320230425
e3af9708-3004-7392-4046-5311eaa8bab5Product name320221128
ffb4bacf-f636-0f7d-0b0d-7a4b151243e3Product name920220928
b72227d6-0388-43bd-995b-b762d2754cd5Product name120220706
a92d22e0-3af4-f301-bc88-27ff030b0070Product name220220316
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
5ce6ce33-4f2b-3ce0-757d-e520013280cfProduct name520180719
b92a26f1-6926-4817-be73-e26ab4c2146fProduct name120170602
028d6c95-5012-6976-2075-dee0ae6fefe2Product name120140508
468b2c08-8adb-8d0f-8257-c6515a061424Product name120140508
8959fb29-d86f-c521-666a-b4cb22233594Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2391-1CLINDAMYCIN PALMITATE HYDROCHLORIDE(Pediatric)100 mL in 1 BOTTLEGRANULE, FOR SOLUTION100107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2391-1ML - Milliliter63629-2391561fe6c6-2440-4816-9355-257f49ac7c3012021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2391CLINDAMYCIN PALMITATE HYDROCHLORIDE (PEDIATRIC) (CLINDAMYCIN PALMITATE HYDROCHLORIDE) GRANULE, FOR SOLUTION [BRYANT RANCH PREPACK]107Current NDC, Legacy NDC, 1 package rows20240905_3afe52c2-b65b-40fe-b2fa-da39f1bcf529.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.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric)CLINDAMYCIN PALMITATE HYDROCHLORIDERising Pharma Holdings, Inc.0800afad-e4cd-4f70-aaa1-a14547be47292025-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201821
application number: ANDA201821
CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric)CLINDAMYCIN PALMITATE HYDROCHLORIDEBryant Ranch Prepack3afe52c2-b65b-40fe-b2fa-da39f1bcf5292024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201821
application number: ANDA201821
ndc (product): 63629-2391
CLINDAMYCIN PALMITATE HYDROCHLORIDE (Pediatric)CLINDAMYCIN PALMITATE HYDROCHLORIDEBryant Ranch Prepack28ba03fd-0f9c-49c6-9bfb-cda5417801c62024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201821
application number: ANDA201821

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562266clindamycin palmitate HCl 75 MG in 5 mL Oral SolutionPSN3afe52c2-b65b-40fe-b2fa-da39f1bcf529107
562266clindamycin 15 MG/ML Oral SolutionSCD3afe52c2-b65b-40fe-b2fa-da39f1bcf529107
562266clindamycin (as clindamycin palmitate HCl) 15 MG/ML Oral SolutionSY3afe52c2-b65b-40fe-b2fa-da39f1bcf529107
562266clindamycin 75 MG per 5 ML Powder for Oral SolutionSY3afe52c2-b65b-40fe-b2fa-da39f1bcf529107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2391-163629239101100 mL in 1 BOTTLE (63629-2391-1) 100 ml2021-02-230000-00-00NoNoCurrent