Daptomycin in Sodium Chloride

Product NDC: 0338-0712
11-digit product format: 003380712
Labeler code: 0338
Product ID: 0338-0712_7b6f75eb-02dd-4906-9ee1-4c658a5e36b3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Daptomycin in Sodium Chloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Corporation
Application: NDA213645
Marketing category: NDA
Marketing start: 2022-01-25
Substance: DAPTOMYCIN
Active strength: 350 mg/50mL
Pharmacologic classes: Lipopeptide Antibacterial [EPC], Lipopeptides [CS]
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 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N213645-001	DAPZURA RT	DAPTOMYCIN	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2022-01-25
N213645-002	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	DAPTOMYCIN	350MG/50ML (7MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27
N213645-003	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	DAPTOMYCIN	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27
N213645-004	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	DAPTOMYCIN	700MG/100ML (7MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27
N213645-005	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	DAPTOMYCIN	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28

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 · 124 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213645-001	DAPZURA RT	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2022-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213645-002	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	350MG/50ML (7MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213645-003	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213645-004	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	700MG/100ML (7MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213645-005	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213645-001	DAPZURA RT	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2022-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213645-002	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	350MG/50ML (7MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213645-003	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213645-004	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	700MG/100ML (7MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213645-005	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213645-001	DAPZURA RT	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2022-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213645-002	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	350MG/50ML (7MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213645-003	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213645-004	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	700MG/100ML (7MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213645-005	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213645-001	DAPZURA RT	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2022-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213645-002	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	350MG/50ML (7MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213645-003	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213645-004	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	700MG/100ML (7MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213645-005	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213645-001	DAPZURA RT	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2022-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213645-002	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	350MG/50ML (7MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213645-003	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213645-004	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	700MG/100ML (7MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213645-005	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213645-001	DAPZURA RT	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2022-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213645-002	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	350MG/50ML (7MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213645-003	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213645-004	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	700MG/100ML (7MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213645-005	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213645-001	DAPZURA RT	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2022-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213645-002	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	350MG/50ML (7MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213645-003	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213645-004	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	700MG/100ML (7MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213645-005	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213645-001	DAPZURA RT	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	POWDER / INTRAVENOUS	RLD	2022-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213645-002	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	350MG/50ML (7MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213645-003	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	500MG/50ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213645-004	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	700MG/100ML (7MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213645-005	DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	1GM/100ML (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-02-27	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213645-001	11173189	2041-03-11	U-3294	Drug product	2022-01-28	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Daptomycin in Sodium Chloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DAPTOMYCIN	350 mg/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NWQ5N31VKK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2632127	Internal RxNorm lookup
2632130	Internal RxNorm lookup
2632132	Internal RxNorm lookup
2632133	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
7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
45ca3ac7-6ee8-4e99-92a6-dc0b401e151a	Product name	1	20250724
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
223d8260-7a4e-4ebd-9635-845422d6a8ad	Product name	9	20240909
ca803a62-3799-476f-bbc6-024f77cb0320	Product name	4	20240207
cad85d83-8fb9-49f8-a5a6-a399af412964	Product name	1	20230922
8e59a5ed-f224-4156-b534-1ae4d0b6dfd7	Product name	1	20230721
ea2c89ab-e8f8-425f-9693-c923fa1e1703	Product name	1	20220929
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-0712-24	Daptomycin in Sodium Chloride	24 in 1 CARTON	INJECTION, SOLUTION	24		10
0338-0712-24	Daptomycin in Sodium Chloride	50 mL in 1 BAG	INJECTION, SOLUTION	50		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-0712-24	ML - Milliliter	0338-0712	32bac834-1f8b-42ff-941e-47285031b991	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-0712	DAPTOMYCIN IN SODIUM CHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	9	Current NDC, 2 package rows	20250508_7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daptomycin in Sodium Chloride	DAPTOMYCIN IN SODIUM CHLORIDE	Baxter Healthcare Corporation	7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213645 application number: NDA213645 ndc (product): 0338-0712
DAPZURA RT	DAPTOMYCIN	Baxter Healthcare Corporation	cb1283e1-35b8-425c-b338-d9ac0c7161f8	2022-01-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213645 application number: NDA213645

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NWQ5N31VKK	DAPTOMYCIN	103060-53-3	DAPTOMYCIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2632127	DAPTOmycin 1000 MG in 100 ML Injection	PSN	7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef	10
2632130	DAPTOmycin 350 MG in 50 ML Injection	PSN	7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef	10
2632132	DAPTOmycin 500 MG in 50 ML Injection	PSN	7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef	10
2632133	DAPTOmycin 700 MG in 100 ML Injection	PSN	7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef	10
2632127	100 ML daptomycin 10 MG/ML Injection	SCD	7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef	10
2632133	100 ML daptomycin 7 MG/ML Injection	SCD	7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef	10
2632132	50 ML daptomycin 10 MG/ML Injection	SCD	7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef	10
2632130	50 ML daptomycin 7 MG/ML Injection	SCD	7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef	10
2632127	daptomycin 1000 MG per 100 ML Injection	SY	7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef	10
2632130	daptomycin 350 MG per 50 ML Injection	SY	7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef	10
2632132	daptomycin 500 MG per 50 ML Injection	SY	7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef	10
2632133	daptomycin 700 MG per 100 ML Injection	SY	7ed4d986-2aa9-43cd-9a8a-fbd11cb5ecef	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0338-0712-24	00338071224	24 BAG in 1 CARTON (0338-0712-24) / 50 mL in 1 BAG	24 bag	2023-02-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Daptomycin in Sodium Chloride	Baxter Healthcare Corporation	2025-04-30	HUMAN PRESCRIPTION DRUG LABEL	10