Fensolvi

Product NDC: 62935-163
11-digit product format: 629350163
Labeler code: 62935
Product ID: 62935-163_6ad49800-db23-42bb-8543-1bbb6a9c96f2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Leuprolide Acetate
Dosage form: INJECTION, SUSPENSION, EXTENDED RELEASE
Route: SUBCUTANEOUS
Labeler: TOLMAR Inc.
Application: NDA213150
Marketing category: NDA
Marketing start: 2023-03-06
Substance: LEUPROLIDE ACETATE
Active strength: 45 mg/.375mL
Pharmacologic classes: Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N213150-001	FENSOLVI KIT	LEUPROLIDE ACETATE	45MG	POWDER / SUBCUTANEOUS		RLD, RS	2020-05-01

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213150-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27
N213150-001	11931559	2041-12-22		Drug substance	2024-04-15
N213150-001	12397120	2041-12-22	U-3611		2025-09-22

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.

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	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213150-001	FENSOLVI KIT	45MG	POWDER / SUBCUTANEOUS	RLD, RS	2020-05-01	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 61 observed states.

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	N213150-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213150-001	12397120	2041-12-22	U-3611		2025-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213150-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213150-001	12397120	2041-12-22	U-3611		2025-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213150-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213150-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213150-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213150-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213150-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213150-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213150-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213150-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213150-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213150-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213150-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213150-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N213150-001	11931559	2041-12-22		Drug substance	2024-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213150-001	8470359	2023-10-15	U-2940	Drug substance, Drug product	2020-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213150-001	8470359	2023-10-15	U-2940	Drug substance, Drug product	2020-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213150-001	8470359	2023-10-15	U-2940	Drug substance, Drug product	2020-08-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213150-001	8470359	2023-10-15	U-2940	Drug substance, Drug product	2020-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213150-001	8470359	2023-10-15	U-2940	Drug substance, Drug product	2020-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213150-001	8470359	2023-10-15	U-2940	Drug substance, Drug product	2020-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213150-001	8470359	2023-10-15	U-2940	Drug substance, Drug product	2020-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213150-001	9539333	2020-11-13		Drug substance, Drug product	2020-08-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N213150-001	9914802	2020-11-13	U-2940	Drug substance, Drug product	2020-08-28	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N213150-001	8470359	2023-10-15	U-2940	Drug substance, Drug product	2020-08-28	`8869cabd3fbd…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213150-001	I-829	2023-05-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213150-001	I-829	2023-05-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213150-001	I-829	2023-05-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213150-001	I-829	2023-05-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213150-001	I-829	2023-05-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N213150-001	I-829	2023-05-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N213150-001	I-829	2023-05-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N213150-001	I-829	2023-05-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N213150-001	I-829	2023-05-01	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N213150-001	I-829	2023-05-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213150-001	I-829	2023-05-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213150-001	I-829	2023-05-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213150-001	I-829	2023-05-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213150-001	I-829	2023-05-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213150-001	I-829	2023-05-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213150-001	I-829	2023-05-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213150-001	I-829	2023-05-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213150-001	I-829	2023-05-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213150-001	I-829	2023-05-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213150-001	I-829	2023-05-01	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEUPROLIDE ACETATE	45 mg/.375mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
37JNS02E7V	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
752884	Internal RxNorm lookup
2371773	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
2c311700-edf4-4f2a-a468-9875489a6cc7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e666f57-491f-16e0-fc75-cc1c9f2fe06f	Product name	4	20250515
43944b95-6cc2-4eca-846a-a5e0ed070616	Product name	1	20240501
f3ff4518-37fe-47a0-8a1e-6ce032a3efd5	Product name	1	20230829
2ed2d111-4d16-4e2a-9b09-7d196056f6c9	Product name	1	20211214
ce98e98f-fa6b-48a6-8ad2-9ef8e8098f26	Product name	1	20200925
23ede539-308f-46e5-817b-41ef23af8d40	Product name	1	20150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4d	Product name	1	20150930
ae18ed71-8057-40ec-987f-83624e50b906	Product name	1	20150122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62935-163-60	2024-01-30	C162847	48780-1	1030e365-5aba-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use FENSOLVI ® safely and effectively. See full prescribing information for FENSOLVI. FENSOLVI (leuprolide acetate) for injectable suspension, for subcutaneous use Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62935-163-60	Fensolvi	0.375 mL in 1 SYRINGE	INJECTION, SUSPENSION, EXTENDED	0.375		12
62935-163-60	Fensolvi	1 in 1 CARTON	INJECTION, SUSPENSION, EXTENDED	1		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62935-163-60	EA - Each	62935-163	c713f3ec-a980-4275-8c17-c2628da9f260	1	2023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62935-163	FENSOLVI (LEUPROLIDE ACETATE) INJECTION, SUSPENSION, EXTENDED RELEASE [TOLMAR INC.]	11	Current NDC, 2 package rows	20241025_2c311700-edf4-4f2a-a468-9875489a6cc7.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
Fensolvi	LEUPROLIDE ACETATE	TOLMAR Inc.	2c311700-edf4-4f2a-a468-9875489a6cc7	2025-09-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213150 application number: NDA213150 ndc (product): 62935-163
Fensolvi	LEUPROLIDE ACETATE	TOLMAR Inc.	dfb6e01c-f138-471d-bf5b-2be38247e3f0	2022-04-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213150 application number: NDA213150

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
37JNS02E7V	LEUPROLIDE ACETATE	74381-53-6	LEUPROLIDE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2371773	Fensolvi 45 MG in 0.375 ML (6 month) Prefilled Syringe	PSN	2c311700-edf4-4f2a-a468-9875489a6cc7	12
752884	leuprolide acetate 45 MG in 0.375 ML (6 month) Prefilled Syringe	PSN	2c311700-edf4-4f2a-a468-9875489a6cc7	12
2371773	0.375 ML leuprolide acetate 120 MG/ML Prefilled Syringe [Fensolvi]	SBD	2c311700-edf4-4f2a-a468-9875489a6cc7	12
752884	0.375 ML leuprolide acetate 120 MG/ML Prefilled Syringe	SCD	2c311700-edf4-4f2a-a468-9875489a6cc7	12
2371773	0.375 ML Fensolvi 120 MG/ML Prefilled Syringe	SY	2c311700-edf4-4f2a-a468-9875489a6cc7	12
2371773	Fensolvi Every 6 Months 45 MG per 0.375 ML Prefilled Syringe	SY	2c311700-edf4-4f2a-a468-9875489a6cc7	12
752884	leuprolide acetate 45 MG per 0.375 ML (6 month) Prefilled Syringe	SY	2c311700-edf4-4f2a-a468-9875489a6cc7	12
752884	leuprolide acetate 45 MG per 0.375 ML Prefilled Syringe	SY	2c311700-edf4-4f2a-a468-9875489a6cc7	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62935-163-60	62935016360	1 SYRINGE in 1 CARTON (62935-163-60) / .375 mL in 1 SYRINGE	1 syringe	2023-03-06	No	No	Current