CLINDAMYCIN HYDROCHLORIDE

Product NDC
67296-1702
Requested package NDC
67296-1702-6
11-digit product format
672961702
Labeler code
67296
Product ID
67296-1702_d61f789c-8313-2d64-e053-2995a90a518d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clindamycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA207402
Marketing category
ANDA
Marketing start
2019-11-01
Marketing end
0000-00-00
Substance
CLINDAMYCIN HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67296-170267296-1702-6IInactivated 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 1 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…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
A207402-001CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05
A207402-002CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-05
A207402-003CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A207402-001AB
A207402-002AB
A207402-003AB

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 UTC2026-02A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207402-002CLINDAMYCIN HYDROCHLORIDEEQ 150MG BASECAPSULE / ORALAB2018-11-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207402-003CLINDAMYCIN HYDROCHLORIDEEQ 300MG BASECAPSULE / ORALAB2018-11-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207402-001CLINDAMYCIN HYDROCHLORIDEEQ 75MG BASECAPSULE / ORALAB2018-11-058072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207402-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207402-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207402-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207402-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207402-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207402-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207402-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207402-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207402-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207402-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207402-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207402-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207402-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207402-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207402-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207402-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207402-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207402-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207402-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207402-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207402-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207402-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207402-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207402-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207402-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207402-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207402-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207402-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207402-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207402-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207402-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207402-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207402-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207402-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207402-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207402-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207402-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207402-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207402-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207402-001AB18072bd15b7f6…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
67296-1702-32024-08-02Clindamycin 150mg
67296-1702-42024-08-02Clindamycin 150mg
67296-1702-62024-08-02Clindamycin 150mg
67296-1702-32024-01-30Clindamycin 150mg
67296-1702-42024-01-30Clindamycin 150mg
67296-1702-62024-01-30Clindamycin 150mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1702-3CLINDAMYCIN HYDROCHLORIDE30 in 1 BOTTLECAPSULE305
67296-1702-4CLINDAMYCIN HYDROCHLORIDE40 in 1 BOTTLECAPSULE405
67296-1702-6CLINDAMYCIN HYDROCHLORIDE60 in 1 BOTTLECAPSULE605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1702CLINDAMYCIN HYDROCHLORIDE CAPSULE [REDPHARM DRUG, INC.]5Legacy NDC, 3 package rows20240805_96b42773-dca4-7e6e-e053-2995a90a49a9.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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEREMEDYREPACK INC.f4c4fce0-0472-45a3-b4c6-192d97ca18182026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.8e3c9cf6-ab39-4fb5-94e3-232880c477002026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.de7001d1-8b83-4f8b-8e50-c076910214562026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepack5f6a85c5-dca3-49b1-a029-3818a41d49bf2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDESt. Mary's Medical Park Pharmacyafeb96ed-7c2e-72d3-e053-2995a90a4ed32026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEMicro Labs Limited9b9f898f-6a91-44f8-9508-f9ddfaad27bc2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.bde81d4b-ad21-cc09-e053-2995a90a8c012026-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.ba9bd5cd-036b-4b0c-e053-2a95a90a332e2026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDERedPharm Drug, Inc.a2f6fa76-a114-4104-e053-2a95a90a9e0b2026-01-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENorthwind Health Company, LLCf6f5c8b2-83a1-5362-e053-6394a90aaaad2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepackcd2ca915-5672-440d-a14e-b4d3b6a522f32025-09-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEDIRECT RXc3f35f80-e4ae-95f5-e053-2995a90a1b642025-07-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEQuality Care Products, LLC1d562ae9-5a9a-4fed-8cc7-3f30fb40f9572024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEBryant Ranch Prepackbea7de4c-c077-4535-96a0-f6b319120b0b2024-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
Clindamycin hydrochlorideCLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.b2bd8402-c887-5bfd-e053-2a95a90a15d92024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEAdvanced Rx of Tennessee, LLC1d760cb7-d166-6707-e063-6394a90a88502024-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.9e68cb17-73d9-8a00-e053-2995a90a517f2024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.9fe44bdd-eb59-4b55-e053-2995a90a31832024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEAvPAKb2a810f1-c009-e973-e053-2a95a90ad5b02024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402
CLINDAMYCIN HYDROCHLORIDECLINDAMYCIN HYDROCHLORIDEAsclemed USA, Inc.7d3e6ec5-93e9-4ce0-8276-b19aa97eb7722023-09-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207402
application number: ANDA207402

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197518clindamycin HCl 150 MG Oral CapsulePSN96b42773-dca4-7e6e-e053-2995a90a49a95
197518clindamycin 150 MG Oral CapsuleSCD96b42773-dca4-7e6e-e053-2995a90a49a95
197518clindamycin (as clindamycin HCl) 150 MG Oral CapsuleSY96b42773-dca4-7e6e-e053-2995a90a49a95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1702-66729617020660 CAPSULE in 1 BOTTLE (67296-1702-6) 60 capsule2020-01-010000-00-00NoNoCurrent