leuprolide acetate

Product NDC: 0121-2106
Requested package NDC: 0121-2106-02
11-digit product format: 001212106
Labeler code: 0121
Product ID: 0121-2106_b1a3e37b-0513-40cc-ab82-a6ec15dc533c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: leuprolide acetate
Dosage form: KIT
Route: SUBCUTANEOUS
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: ANDA217957
Marketing category: ANDA
Marketing start: 2025-02-01
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 43.

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
A217957-001	LEUPROLIDE ACETATE	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP		2024-10-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217957-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217957-001	LEUPROLIDE ACETATE	14MG/2.8ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	AP	2024-10-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217957-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217957-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217957-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217957-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217957-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217957-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217957-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217957-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217957-001	AP	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217957-001	AP	1	`d8e5a09893c0…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217957-001	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
545835	Internal RxNorm lookup
797544	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
19be0b7f-e68a-4547-9e49-b51b12821907	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
f3ff4518-37fe-47a0-8a1e-6ce032a3efd5	Product name	1	20230829
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
2ed2d111-4d16-4e2a-9b09-7d196056f6c9	Product name	1	20211214
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
ce98e98f-fa6b-48a6-8ad2-9ef8e8098f26	Product name	1	20200925
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
23ede539-308f-46e5-817b-41ef23af8d40	Product name	1	20150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4d	Product name	1	20150930
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
ae18ed71-8057-40ec-987f-83624e50b906	Product name	1	20150122
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0121-1053-02	leuprolide acetate	2.8 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	2.8 mL	5 mg in 1mL	4
0121-1053-02	leuprolide acetate	1 in 1 CARTON	INJECTION, SOLUTION		5 mg in 1mL	4
0121-2105-01	leuprolide acetate	1 mL in 1 PACKET	SWAB	28 mL	0.7 mL in 1mL	4
0121-2106-02	leuprolide acetate	1 in 1 CARTON	KIT	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-2106-02	EA - Each	0121-2106	d7be06c2-7ade-49aa-98b0-ef95ef0445a6	1	2025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-2106	LEUPROLIDE ACETATE KIT [PAI HOLDINGS, LLC DBA PAI PHARMA]	3	Current NDC, 4 package rows	20250201_19be0b7f-e68a-4547-9e49-b51b12821907.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
leuprolide acetate	LEUPROLIDE ACETATE	UBI Pharma Inc.	cd46628f-055f-4da9-8c38-fa69af34eb4d	2026-03-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217957 application number: ANDA217957
leuprolide acetate	LEUPROLIDE ACETATE	PAI Holdings, LLC dba PAI Pharma	19be0b7f-e68a-4547-9e49-b51b12821907	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217957 application number: ANDA217957 ndc (package): 0121-2106-02 ndc (product): 0121-2106 ndc11 (package): 00121210602

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
797544	isopropyl alcohol 70 % Medicated Pad	PSN	19be0b7f-e68a-4547-9e49-b51b12821907	4
545835	leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable Solution	PSN	19be0b7f-e68a-4547-9e49-b51b12821907	4
797544	isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD	19be0b7f-e68a-4547-9e49-b51b12821907	4
545835	leuprolide acetate 5 MG/ML Injectable Solution	SCD	19be0b7f-e68a-4547-9e49-b51b12821907	4
797544	isopropyl alcohol 70 % Medicated Pad	SY	19be0b7f-e68a-4547-9e49-b51b12821907	4
797544	isopropyl alcohol 70 % Topical Cloth	SY	19be0b7f-e68a-4547-9e49-b51b12821907	4
797544	isopropyl alcohol 70 % Topical Swab	SY	19be0b7f-e68a-4547-9e49-b51b12821907	4
545835	leuprolide acetate 1 MG per 0.2 ML Injectable Solution	SY	19be0b7f-e68a-4547-9e49-b51b12821907	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0121-2106-02	00121210602	1 KIT in 1 CARTON (0121-2106-02) * 1 VIAL, MULTI-DOSE in 1 CARTON (0121-1053-02) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (0121-2105-01)	1 kit	2025-02-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Leuprolide Acetate Injection (leuprolide acetate) Rx only	PAI Holdings, LLC dba PAI Pharma	2026-01-16	HUMAN PRESCRIPTION DRUG LABEL	4