Treprostinil

Product NDC: 62332-515
Requested package NDC: 62332-515-20
11-digit product format: 623320515
Labeler code: 62332
Product ID: 62332-515_5384ef7c-88cc-4ab7-8eb7-627eba752f9d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Treprostinil
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Alembic Pharmaceuticals Inc.
Application: ANDA211574
Marketing category: ANDA
Marketing start: 2021-02-11
Substance: TREPROSTINIL
Active strength: 50 mg/20mL
Pharmacologic classes: Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62332-515	62332-515-20	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211574-001	TREPROSTINIL	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11
A211574-002	TREPROSTINIL	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11
A211574-003	TREPROSTINIL	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11
A211574-004	TREPROSTINIL	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A211574-001	AP
A211574-002	AP
A211574-003	AP
A211574-004	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 · 140 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	A211574-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211574-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211574-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211574-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211574-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211574-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211574-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211574-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211574-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211574-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211574-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211574-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211574-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211574-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211574-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211574-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211574-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211574-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211574-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211574-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211574-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211574-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211574-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211574-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211574-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211574-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211574-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211574-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211574-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211574-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211574-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211574-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211574-001	TREPROSTINIL	1MG/ML	INJECTABLE / IV (INFUSION), SUBCUTANEOUS	AP	2021-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211574-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / IV (INFUSION), SUBCUTANEOUS	AP	2021-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211574-003	TREPROSTINIL	5MG/ML	INJECTABLE / IV (INFUSION), SUBCUTANEOUS	AP	2021-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211574-004	TREPROSTINIL	10MG/ML	INJECTABLE / IV (INFUSION), SUBCUTANEOUS	AP	2021-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211574-001	TREPROSTINIL	1MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211574-002	TREPROSTINIL	2.5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211574-003	TREPROSTINIL	5MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211574-004	TREPROSTINIL	10MG/ML	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2021-02-11	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 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	A211574-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211574-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211574-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211574-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211574-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211574-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211574-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211574-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211574-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211574-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211574-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211574-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211574-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211574-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211574-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211574-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211574-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211574-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211574-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211574-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211574-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211574-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211574-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211574-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211574-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211574-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211574-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211574-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211574-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211574-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211574-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211574-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211574-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211574-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211574-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211574-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211574-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211574-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211574-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211574-004	AP	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Treprostinil
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TREPROSTINIL	50 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
RUM6K67ESG	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349407	Internal RxNorm lookup
349408	Internal RxNorm lookup
349409	Internal RxNorm lookup
349410	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
4a684b13-669d-4721-8ed4-30cc7762b0b8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d31d7280-9cbd-4e8c-ad8c-a830d9d6c4bf	Product name	1	20260309
3a764347-294a-401b-979f-44c1c6bb101a	Product name	1	20230126
5e14eefc-ad08-9fbf-a28c-67c518b16369	Product name	5	20210727
799cd7a2-692a-4730-993b-8b702e954a56	Product name	1	20200407

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62332-515-20	Treprostinil	1 in 1 CARTON	INJECTION, SOLUTION	1		8
62332-515-20	Treprostinil	20 mL in 1 VIAL	INJECTION, SOLUTION	20		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62332-515	TREPROSTINIL INJECTION, SOLUTION [ALEMBIC PHARMACEUTICALS INC.]	8	Current NDC, Legacy NDC, 2 package rows	20250313_4a684b13-669d-4721-8ed4-30cc7762b0b8.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Treprostinil	TREPROSTINIL	Alembic Pharmaceuticals Inc.	4a684b13-669d-4721-8ed4-30cc7762b0b8	2025-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211574 application number: ANDA211574 ndc (package): 62332-515-20 ndc (product): 62332-515 ndc11 (package): 62332051520

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RUM6K67ESG	TREPROSTINIL	81846-19-7	TREPROSTINIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349407	treprostinil 1 MG/ML Injectable Solution	PSN	4a684b13-669d-4721-8ed4-30cc7762b0b8	8
349408	treprostinil 10 MG/ML Injectable Solution	PSN	4a684b13-669d-4721-8ed4-30cc7762b0b8	8
349409	treprostinil 2.5 MG/ML Injectable Solution	PSN	4a684b13-669d-4721-8ed4-30cc7762b0b8	8
349410	treprostinil 5 MG/ML Injectable Solution	PSN	4a684b13-669d-4721-8ed4-30cc7762b0b8	8
349407	treprostinil 1 MG/ML Injectable Solution	SCD	4a684b13-669d-4721-8ed4-30cc7762b0b8	8
349408	treprostinil 10 MG/ML Injectable Solution	SCD	4a684b13-669d-4721-8ed4-30cc7762b0b8	8
349409	treprostinil 2.5 MG/ML Injectable Solution	SCD	4a684b13-669d-4721-8ed4-30cc7762b0b8	8
349410	treprostinil 5 MG/ML Injectable Solution	SCD	4a684b13-669d-4721-8ed4-30cc7762b0b8	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62332-515-20	62332051520	1 VIAL in 1 CARTON (62332-515-20) / 20 mL in 1 VIAL	1 vial	2021-02-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Treprostinil	Alembic Pharmaceuticals Inc. \| Corden Pharma S.p.A.	2025-02-13	Human Prescription Drug Label	8