Eligard

Product NDC: 62935-306
11-digit product format: 629350306
Labeler code: 62935
Product ID: 62935-306_58cff066-4345-4624-8868-4c232a051a5d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Leuprolide acetate
Dosage form: INJECTION, SUSPENSION, EXTENDED RELEASE
Route: SUBCUTANEOUS
Labeler: TOLMAR Inc.
Application: NDA021488
Marketing category: NDA
Marketing start: 2024-01-11
Substance: LEUPROLIDE ACETATE
Active strength: 30 mg/.5mL
Pharmacologic classes: Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021488-001	ELIGARD KIT	LEUPROLIDE ACETATE	30MG	POWDER / SUBCUTANEOUS		RLD, RS	2003-02-13

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
N021488-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27
N021488-001	11931559	2041-12-22		Drug substance	2024-04-15
N021488-001	12397120	2041-12-22	U-4001		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.

Product history page 1 of 2 · 41 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	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021488-001	ELIGARD	30MG/VIAL	INJECTABLE / SUBCUTANEOUS	RLD, RS	2003-02-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021488-001	ELIGARD	30MG/VIAL	INJECTABLE / SUBCUTANEOUS	RLD, RS	2003-02-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021488-001	ELIGARD	30MG/VIAL	INJECTABLE / SUBCUTANEOUS	RLD, RS	2003-02-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021488-001	ELIGARD	30MG/VIAL	INJECTABLE / SUBCUTANEOUS	RLD, RS	2003-02-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021488-001	ELIGARD KIT	30MG	POWDER / SUBCUTANEOUS	RLD, RS	2003-02-13	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 79 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	N021488-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021488-001	11931559	2041-12-22		Drug substance	2024-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021488-001	12397120	2041-12-22	U-4001		2025-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021488-001	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	N021488-001	11931559	2041-12-22		Drug substance	2024-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021488-001	12397120	2041-12-22	U-4001		2025-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021488-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021488-001	11931559	2041-12-22		Drug substance	2024-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021488-001	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	N021488-001	11931559	2041-12-22		Drug substance	2024-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021488-001	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	N021488-001	11931559	2041-12-22		Drug substance	2024-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021488-001	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	N021488-001	11931559	2041-12-22		Drug substance	2024-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021488-001	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	N021488-001	11931559	2041-12-22		Drug substance	2024-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021488-001	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	N021488-001	11931559	2041-12-22		Drug substance	2024-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021488-001	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	N021488-001	11931559	2041-12-22		Drug substance	2024-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021488-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021488-001	11931559	2041-12-22		Drug substance	2024-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021488-001	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	N021488-001	11931559	2041-12-22		Drug substance	2024-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021488-001	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	N021488-001	11931559	2041-12-22		Drug substance	2024-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021488-001	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	N021488-001	11931559	2041-12-22		Drug substance	2024-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021488-001	11771841	2041-12-22		Drug substance, Drug product	2023-10-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021488-001	11931559	2041-12-22		Drug substance	2024-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021488-001	8470359	2023-10-15	U-621	Drug substance, Drug product	2017-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021488-001	8470359	2023-10-15	U-621	Drug substance, Drug product	2017-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021488-001	8470359	2023-10-15	U-621	Drug substance, Drug product	2017-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021488-001	6626870	2020-03-27		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021488-001	8840916	2020-11-13		Drug product	2017-01-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021488-001	9539333	2020-11-13	U-621	Drug substance, Drug product	2017-01-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021488-001	8470359	2023-10-15	U-621	Drug substance, Drug product	2017-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021488-001	8470359	2023-10-15	U-621	Drug substance, Drug product	2017-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021488-001	8470359	2023-10-15	U-621	Drug substance, Drug product	2017-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021488-001	8470359	2023-10-15	U-621	Drug substance, Drug product	2017-01-31	`87673890dc5c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEUPROLIDE ACETATE	30 mg/.5mL

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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
752884	Internal RxNorm lookup
752889	Internal RxNorm lookup
752894	Internal RxNorm lookup
752899	Internal RxNorm lookup
825325	Internal RxNorm lookup
825333	Internal RxNorm lookup
825334	Internal RxNorm lookup
825335	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
b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62935-306-40	Eligard	0.5 mL in 1 SYRINGE	INJECTION, SUSPENSION, EXTENDED	0.5		19
62935-306-40	Eligard	1 in 1 CARTON	INJECTION, SUSPENSION, EXTENDED	1		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62935-306-40	EA - Each	62935-306	06a50dd8-4b26-46fb-90a2-897177346f8a	1	2024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62935-306	ELIGARD (LEUPROLIDE ACETATE) INJECTION, SUSPENSION, EXTENDED RELEASE [TOLMAR INC.]	18	Current NDC, 2 package rows	20250228_b7b679a9-6823-4ef8-8d31-3ab5058ffcfc.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
Vabrinty	LEUPROLIDE ACETATE	URONOVA PHARMACEUTICALS, INC.	008776cc-83f1-4f8c-819b-6471425da15f	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021488 application number: NDA021488
Eligard	LEUPROLIDE ACETATE	TOLMAR Inc.	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021488 application number: NDA021488 ndc (product): 62935-306
ELIGARD	LEUPROLIDE ACETATE	TOLMAR Inc.	b78d1919-9dee-44fa-90f9-e0a26d32481d	2019-04-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021488 application number: NDA021488

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
825335	Eligard 22.5 MG in 0.375 ML (3 month) Prefilled Syringe	PSN	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
825333	Eligard 30 MG in 0.5 ML (4 month) Prefilled Syringe	PSN	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
825325	Eligard 45 MG in 0.375 ML (6 month) Prefilled Syringe	PSN	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
825334	Eligard 7.5 MG in 0.25 ML (1 month) Prefilled Syringe	PSN	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
752894	leuprolide acetate 22.5 MG in 0.375 mL (3 month) Prefilled Syringe	PSN	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
752889	leuprolide acetate 30 MG in 0.5 ML (4 month) Prefilled Syringe	PSN	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
752884	leuprolide acetate 45 MG in 0.375 ML (6 month) Prefilled Syringe	PSN	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
752899	leuprolide acetate 7.5 MG in 0.25 ML (1 month) Prefilled Syringe	PSN	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
825334	0.25 ML leuprolide acetate 30 MG/ML Prefilled Syringe [Eligard]	SBD	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
825325	0.375 ML leuprolide acetate 120 MG/ML Prefilled Syringe [Eligard]	SBD	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
825335	0.375 ML leuprolide acetate 60 MG/ML Prefilled Syringe [Eligard]	SBD	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
825333	0.5 ML leuprolide acetate 60 MG/ML Prefilled Syringe [Eligard]	SBD	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
752899	0.25 ML leuprolide acetate 30 MG/ML Prefilled Syringe	SCD	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
752884	0.375 ML leuprolide acetate 120 MG/ML Prefilled Syringe	SCD	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
752894	0.375 ML leuprolide acetate 60 MG/ML Prefilled Syringe	SCD	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
752889	0.5 ML leuprolide acetate 60 MG/ML Prefilled Syringe	SCD	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
825334	0.25 ML Eligard 30 MG/ML Prefilled Syringe	SY	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
825325	0.375 ML Eligard 120 MG/ML Prefilled Syringe	SY	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
825335	0.375 ML Eligard 60 MG/ML Prefilled Syringe	SY	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
825333	0.5 ML Eligard 60 MG/ML Prefilled Syringe	SY	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
825335	Eligard 22.5 MG per 0.375 ML Prefilled Syringe	SY	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
825333	Eligard 30 MG per 0.5 ML Prefilled Syringe	SY	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
825325	Eligard 45 MG per 0.375 ML Prefilled Syringe	SY	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
825334	Eligard 7.5 MG per 0.25 ML Prefilled Syringe	SY	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
825335	Eligard Every 3 Months 22.5 MG per 0.375 ML Prefilled Syringe	SY	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
825333	Eligard Every 4 Months 30 MG per 0.5 ML Prefilled Syringe	SY	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
825325	Eligard Every 6 Months 45 MG per 0.375 ML Prefilled Syringe	SY	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
825334	Eligard Monthly 7.5 MG per 0.25 ML Prefilled Syringe	SY	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
752894	leuprolide acetate 22.5 MG per 0.375 ML (3 month) Prefilled Syringe	SY	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
752894	leuprolide acetate 22.5 MG per 0.375 ML Prefilled Syringe	SY	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
752889	leuprolide acetate 30 MG per 0.5 ML (4 month) Prefilled Syringe	SY	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
752884	leuprolide acetate 45 MG per 0.375 ML (6 month) Prefilled Syringe	SY	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
752884	leuprolide acetate 45 MG per 0.375 ML Prefilled Syringe	SY	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19
752899	leuprolide acetate 7.5 MG per 0.25 ML Prefilled Syringe	SY	b7b679a9-6823-4ef8-8d31-3ab5058ffcfc	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62935-306-40	62935030640	1 SYRINGE in 1 CARTON (62935-306-40) / .5 mL in 1 SYRINGE	1 syringe	2024-01-11	No	No	Current