FDA.reportPublic FDA data

LEUPROLIDE ACETATE

Product NDC
70771-1687
Requested package NDC
70771-1687-3
11-digit product format
707711687
Labeler code
70771
Product ID
70771-1687_ebf565fd-e894-45ad-8b0b-8b94bdf375d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEUPROLIDE ACETATE
Dosage form
KIT
Labeler
Zydus Lifesciences Limited
Application
ANDA215826
Marketing category
ANDA
Marketing start
2026-01-08
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215826-001LEUPROLIDE ACETATELEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSAP2025-11-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215826-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A215826-001LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSAP2025-11-1384e616aacf4f…
2026-08-18 06:07:402026-07A215826-001LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSAP2025-11-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215826-001LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSAP2025-11-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215826-001LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSAP2025-11-1331067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215826-001LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSAP2025-11-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A215826-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A215826-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215826-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215826-001AP131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215826-001AP1a50c72e98297…

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
IdentifierFDA.report destination
545835Internal RxNorm lookup
797544Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4bae0e2a-dd36-4987-85ee-36a52e642ec7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e666f57-491f-16e0-fc75-cc1c9f2fe06fProduct name420250515
43944b95-6cc2-4eca-846a-a5e0ed070616Product name120240501
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
f3ff4518-37fe-47a0-8a1e-6ce032a3efd5Product name120230829
2ed2d111-4d16-4e2a-9b09-7d196056f6c9Product name120211214
ce98e98f-fa6b-48a6-8ad2-9ef8e8098f26Product name120200925
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
23ede539-308f-46e5-817b-41ef23af8d40Product name120150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4dProduct name120150930
ae18ed71-8057-40ec-987f-83624e50b906Product name120150122
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1686-1LEUPROLIDE ACETATE2.8 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION2.8 mL1 mg in 0.2mL3
70771-1686-1LEUPROLIDE ACETATE1 in 1 CARTONINJECTION, SOLUTION1 mg in 0.2mL3
70771-1687-3LEUPROLIDE ACETATE1 in 1 CARTONKIT13
70771-1765-8LEUPROLIDE ACETATE1 mL in 1 PACKETSWAB1 mL0.7 mL in 1mL3

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEUPROLIDE ACETATELEUPROLIDE ACETATEZydus Pharmaceuticals USA Inc.35634415-000f-47db-9bd7-9e16eef3f02e2026-05-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215826
application number: ANDA215826
LEUPROLIDE ACETATELEUPROLIDE ACETATEZydus Lifesciences Limited4bae0e2a-dd36-4987-85ee-36a52e642ec72026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215826
application number: ANDA215826
ndc (package): 70771-1687-3
ndc (product): 70771-1687
ndc11 (package): 70771168703

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797544isopropyl alcohol 70 % Medicated PadPSN4bae0e2a-dd36-4987-85ee-36a52e642ec73
545835leuprolide acetate 1 MG/0.2 ML (5 MG/ML) Injectable SolutionPSN4bae0e2a-dd36-4987-85ee-36a52e642ec73
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD4bae0e2a-dd36-4987-85ee-36a52e642ec73
545835leuprolide acetate 5 MG/ML Injectable SolutionSCD4bae0e2a-dd36-4987-85ee-36a52e642ec73
797544isopropyl alcohol 70 % Medicated PadSY4bae0e2a-dd36-4987-85ee-36a52e642ec73
797544isopropyl alcohol 70 % Topical ClothSY4bae0e2a-dd36-4987-85ee-36a52e642ec73
797544isopropyl alcohol 70 % Topical SwabSY4bae0e2a-dd36-4987-85ee-36a52e642ec73
545835leuprolide acetate 1 MG per 0.2 ML Injectable SolutionSY4bae0e2a-dd36-4987-85ee-36a52e642ec73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1687-3707711687031 KIT in 1 CARTON (70771-1687-3) * 1 VIAL, MULTI-DOSE in 1 CARTON (70771-1686-1) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (70771-1765-8) 1 kit2026-01-08NoNoCurrent