Clindamycin Hydrochloride

Product NDC
61919-829
11-digit product format
619190829
Labeler code
61919
Product ID
61919-829_30a7ab46-70c7-43fb-b643-b9fbf931b288
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct Rx
Application
ANDA065243
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
CLINDAMYCIN HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-829IInactivated by FDA2026-08-03
excluded packagepackage61919-82961919-829-21IInactivated by FDA2026-08-03
excluded packagepackage61919-82961919-829-30IInactivated by FDA2026-08-03
excluded packagepackage61919-82961919-829-40IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 88 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-829-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-829-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-829-21d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-829-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-829-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-829-21f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-829-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-829-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-829-212ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-829-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-829-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-829-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-829-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-829-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-829-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-829-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-829-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-829-21cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-829-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-829-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-829-21302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-829-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-829-40ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-829-21ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-829-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-829-400efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-829-210efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-829-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-829-40ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-829-21ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-829-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-829-40367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-829-21367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-829-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-829-40557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-829-21557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-829-308af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-829-408af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-829-218af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-829-30834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-829-40834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-829-21834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-829-301332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-829-401332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-829-211332a3947898…d4bfe170f9cd…

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065243-001CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-12
A065243-002CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-12
A065243-003CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065243-002AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065243-002CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2005-08-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065243-003CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORAL2005-08-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065243-001CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORAL2005-08-128072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 53 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065243-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065243-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065243-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065243-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065243-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065243-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065243-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065243-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065243-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065243-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065243-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065243-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065243-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065243-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065243-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065243-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065243-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065243-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065243-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065243-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065243-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065243-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065243-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065243-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065243-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A065243-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A065243-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065243-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A065243-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A065243-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065243-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A065243-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A065243-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065243-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A065243-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A065243-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065243-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A065243-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A065243-003AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065243-002AB16a51e52b5d6a…

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-829-21Clindamycin Hydrochloride21 in 1 BOTTLECAPSULE212
61919-829-30Clindamycin Hydrochloride30 in 1 BOTTLECAPSULE302
61919-829-40Clindamycin Hydrochloride40 in 1 BOTTLECAPSULE402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-829-21EA - Each61919-82971a1a50c-fb05-4e03-bd73-0228c1db4d6012016-09-02
61919-829-30EA - Each61919-8297bb3941b-0f6f-470a-af3e-f5282ba0ecde12016-09-02
61919-829-40EA - Each61919-82976f8dad3-727d-498c-9f53-7eb4da5f04a012016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLINDAMYCIN HYDROCHLORIDEACTIVE INGREDIENTT20OQ1YN1WCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
CLINDAMYCINACTIVE MOIETY3U02EL437CCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
GELATININACTIVE INGREDIENT2G86QN327LCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
SHELLACINACTIVE INGREDIENT46N107B71OCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-829CLINDAMYCIN HYDROCHLORIDE CAPSULE [DIRECT RX]2Legacy NDC, 3 package rows20151112_075dbfb1-47c2-4578-a212-f8e656f0e9f9.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clindamycin HydrochlorideCLINDAMYCIN HYDROCHLORIDEChartwell RX, LLCe8167412-882e-4143-93c6-49e68adbcf162024-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065243
application number: ANDA065243

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284215clindamycin HCl 300 MG Oral CapsulePSN075dbfb1-47c2-4578-a212-f8e656f0e9f92
284215clindamycin 300 MG Oral CapsuleSCD075dbfb1-47c2-4578-a212-f8e656f0e9f92
284215clindamycin (as clindamycin HCl) 300 MG Oral CapsuleSY075dbfb1-47c2-4578-a212-f8e656f0e9f92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-829-216191908292121 in 1 BOTTLEHistorical
61919-829-306191908293030 in 1 BOTTLEHistorical
61919-829-406191908294040 in 1 BOTTLEHistorical