Clindamycin phosphate

Product NDC: 0338-3612
11-digit product format: 003383612
Labeler code: 0338
Product ID: 0338-3612_c8906ab2-37d2-4fde-9784-0442bf7b9565
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clindamycin phosphate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Company
Application: ANDA208084
Marketing category: ANDA
Marketing start: 2017-06-28
Substance: CLINDAMYCIN PHOSPHATE
Active strength: 600 mg/50mL
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208084-001	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	CLINDAMYCIN PHOSPHATE	EQ 6MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28
A208084-002	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	CLINDAMYCIN PHOSPHATE	EQ 12MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28
A208084-003	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	CLINDAMYCIN PHOSPHATE	EQ 18MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208084-001	AP
A208084-002	AP
A208084-003	AP

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A208084-001	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208084-002	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208084-003	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 18MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208084-001	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208084-002	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208084-003	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 18MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208084-001	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208084-002	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208084-003	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 18MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208084-001	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208084-002	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208084-003	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 18MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208084-001	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208084-002	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208084-003	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 18MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208084-001	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208084-002	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208084-003	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 18MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208084-001	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208084-002	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208084-003	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 18MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208084-001	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208084-002	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208084-003	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 18MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208084-001	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208084-002	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208084-003	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 18MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208084-001	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208084-002	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208084-003	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 18MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208084-001	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208084-002	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208084-003	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 18MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208084-001	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208084-002	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208084-003	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 18MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208084-001	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208084-002	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 12MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208084-003	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 18MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208084-001	CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER	EQ 6MG BASE/ML	INJECTABLE / INJECTION	AP	2017-06-28	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208084-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208084-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208084-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208084-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208084-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208084-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208084-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208084-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208084-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208084-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208084-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208084-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208084-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208084-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208084-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208084-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208084-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208084-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208084-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208084-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208084-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208084-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208084-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208084-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208084-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208084-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208084-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208084-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208084-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208084-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208084-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208084-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208084-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208084-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208084-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208084-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208084-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208084-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208084-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208084-001	AP	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: Clindamycin phosphate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLINDAMYCIN PHOSPHATE	600 mg/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EH6D7113I8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309335	Internal RxNorm lookup
309336	Internal RxNorm lookup
309339	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
78832ac6-04c5-45e0-ae4d-f56d7920dda9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a46239a7-5963-4008-8cbb-6b9000f497eb	Product name	1	20250721
1426d8f8-b7d5-4053-8554-613df00c0d86	Product name	2	20250616
b382b4e1-6b48-45f6-bffc-e61b00b0ce19	Product name	3	20250317
d8f81258-db12-0761-46cc-8ff6e62e9302	Product name	4	20240422
b7b2fa42-1c77-d724-81f0-87da60a77e79	Product name	3	20240320
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
b27c7c65-51f2-a62f-e0e6-a26b3a0f8eb0	Product name	3	20230425
e3af9708-3004-7392-4046-5311eaa8bab5	Product name	3	20221128
ffb4bacf-f636-0f7d-0b0d-7a4b151243e3	Product name	9	20220928
b72227d6-0388-43bd-995b-b762d2754cd5	Product name	1	20220706
a92d22e0-3af4-f301-bc88-27ff030b0070	Product name	2	20220316
4a7d44fe-774d-404b-aad0-8a90fe78375a	Product name	4	20211025
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27b	Product name	3	20200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992	Product name	4	20190619
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
5ce6ce33-4f2b-3ce0-757d-e520013280cf	Product name	5	20180719
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
b92a26f1-6926-4817-be73-e26ab4c2146f	Product name	1	20170602
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
028d6c95-5012-6976-2075-dee0ae6fefe2	Product name	1	20140508
468b2c08-8adb-8d0f-8257-c6515a061424	Product name	1	20140508
8959fb29-d86f-c521-666a-b4cb22233594	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-3612-24	Clindamycin phosphate	24 in 1 CARTON	INJECTION, SOLUTION	24		15
0338-3612-50	Clindamycin phosphate	50 mL in 1 BAG	INJECTION, SOLUTION	50		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-3612-24	ML - Milliliter	0338-3612	af08c1cb-25b8-4c28-8690-964db82789d0	1	2017-08-11
0338-3612-50	ML - Milliliter	0338-3612	3cee30d6-6fbc-4695-b4a2-9de193c49f74	1	2017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-3612	CLINDAMYCIN PHOSPHATE INJECTION, SOLUTION [BAXTER HEALTHCARE COMPANY]	13	Current NDC, Legacy NDC, 2 package rows	20250323_78832ac6-04c5-45e0-ae4d-f56d7920dda9.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Baxter Healthcare Corporation	1a42c3b2-90b5-4a78-9f18-fa789742b033	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208084 application number: ANDA208084
Clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Baxter Healthcare Company	406534a6-2234-4735-ba8f-7de4c87592e6	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208084 application number: ANDA208084
Clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Baxter Healthcare Company	78832ac6-04c5-45e0-ae4d-f56d7920dda9	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208084 application number: ANDA208084 ndc (product): 0338-3612

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EH6D7113I8	CLINDAMYCIN PHOSPHATE	24729-96-2	CLINDAMYCIN PHOSPHATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309339	clindamycin 300 MG in 50 ML Injection	PSN	78832ac6-04c5-45e0-ae4d-f56d7920dda9	15
309335	clindamycin 600 MG in 50 ML Injection	PSN	78832ac6-04c5-45e0-ae4d-f56d7920dda9	15
309336	clindamycin 900 MG in 50 ML Injection	PSN	78832ac6-04c5-45e0-ae4d-f56d7920dda9	15
309335	50 ML clindamycin 12 MG/ML Injection	SCD	78832ac6-04c5-45e0-ae4d-f56d7920dda9	15
309336	50 ML clindamycin 18 MG/ML Injection	SCD	78832ac6-04c5-45e0-ae4d-f56d7920dda9	15
309339	50 ML clindamycin 6 MG/ML Injection	SCD	78832ac6-04c5-45e0-ae4d-f56d7920dda9	15
309339	clindamycin (as clindamycin phosphate) 300 MG per 50 ML Injection	SY	78832ac6-04c5-45e0-ae4d-f56d7920dda9	15
309335	clindamycin (as clindamycin phosphate) 600 MG per 50 ML Injection	SY	78832ac6-04c5-45e0-ae4d-f56d7920dda9	15
309336	clindamycin (as clindamycin phosphate) 900 MG per 50 ML Injection	SY	78832ac6-04c5-45e0-ae4d-f56d7920dda9	15
309335	clindamycin 600 MG per 50 ML Injection	SY	78832ac6-04c5-45e0-ae4d-f56d7920dda9	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0338-3612-24	00338361224	24 BAG in 1 CARTON (0338-3612-24) / 50 mL in 1 BAG (0338-3612-50)	24 bag	2017-06-28	0000-00-00	No	No	Current
0338-3612-50	00338361250	50 mL in 1 BAG	50 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLINDAMYCIN INJECTION USP IN 5% DEXTROSE	Baxter Healthcare Company \| Baxter Healthcare Corporation	2026-04-28	HUMAN PRESCRIPTION DRUG LABEL	15