LYLLANA

Product NDC: 65162-148
11-digit product format: 651620148
Labeler code: 65162
Product ID: 65162-148_6828b547-27f6-4099-981f-a8efcba66370
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Estradiol
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA211396
Marketing category: ANDA
Marketing start: 2020-09-30
Substance: ESTRADIOL
Active strength: .0375 mg/d
Pharmacologic classes: Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
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 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211396-001	ESTRADIOL	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28
A211396-002	ESTRADIOL	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28
A211396-003	ESTRADIOL	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28
A211396-004	ESTRADIOL	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28
A211396-005	ESTRADIOL	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A211396-001	AB3
A211396-002	AB3
A211396-003	AB3
A211396-004	AB3
A211396-005	AB3

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 5 · 185 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
2026-02-19 14:30 UTC	2026-02	A211396-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211396-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211396-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211396-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211396-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211396-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211396-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211396-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211396-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211396-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211396-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211396-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211396-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211396-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211396-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211396-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211396-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211396-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211396-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211396-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211396-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211396-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211396-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211396-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211396-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211396-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211396-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211396-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211396-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211396-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211396-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211396-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211396-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211396-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211396-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211396-001	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211396-002	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211396-003	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211396-004	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211396-005	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB3	2020-09-28	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 185 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211396-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211396-002	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211396-003	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211396-004	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211396-005	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211396-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211396-002	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211396-003	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211396-004	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211396-005	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211396-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211396-002	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211396-003	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211396-004	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211396-005	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211396-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211396-002	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211396-003	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211396-004	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211396-005	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211396-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211396-002	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211396-003	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211396-004	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211396-005	AB3	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211396-001	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211396-002	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211396-003	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211396-004	AB3	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211396-005	AB3	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211396-001	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211396-002	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211396-003	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211396-004	AB3	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211396-005	AB3	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211396-001	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211396-002	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211396-003	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211396-004	AB3	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211396-005	AB3	1	`5bbf6a4d5a75…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTRADIOL	.0375 mg/d

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4TI98Z838E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
241946	Internal RxNorm lookup
242891	Internal RxNorm lookup
242892	Internal RxNorm lookup
248478	Internal RxNorm lookup
1149632	Internal RxNorm lookup
2399892	Internal RxNorm lookup
2399895	Internal RxNorm lookup
2399898	Internal RxNorm lookup
2399901	Internal RxNorm lookup
2399904	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
09c472c6-a38a-4a3d-b048-6fefd52e2ad3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379	Product name	2	20250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6	Product name	2	20250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1	Product name	6	20250311
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbf	Product name	2	20250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1	Product name	3	20240507
66263a7f-f64d-41c4-90f1-2cee106617cc	Product name	1	20240501
76820076-f087-4073-b1d1-aa04b361335e	Product name	2	20220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94	Product name	3	20220126
0a040ba8-1f34-4328-bb07-4f64503daaab	Product name	2	20210513
833edb59-a012-45c2-aff5-2ed74b66fa59	Product name	1	20201207
f4d31098-441e-52d3-27f1-49c829f8a3a1	Product name	5	20190703
001f367b-fa14-49a0-865b-b395f2553601	Product name	2	20190611
3f090665-4687-4bb4-8790-8efb1930ee74	Product name	1	20180801
7a549f52-8b99-472c-8b1d-3a70c53c9bf4	Product name	1	20160623
3ca8d96e-517a-05ea-5690-f8e1d3726540	Product name	1	20140508
5f44c957-835a-ada0-662f-5b1071b7a68b	Product name	1	20140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183	Product name	1	20140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4	Product name	1	20140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4	Product name	1	20140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65162-148-04	LYLLANA	1 d in 1 POUCH	PATCH, EXTENDED RELEASE	1		15
65162-148-08	LYLLANA	8 in 1 CARTON	PATCH, EXTENDED RELEASE	8		15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-148	LYLLANA (ESTRADIOL) PATCH, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]	15	Current NDC, Legacy NDC, 2 package rows	20240607_09c472c6-a38a-4a3d-b048-6fefd52e2ad3.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
Estradiol	ESTRADIOL	Amneal Pharmaceuticals NY LLC	d4259bb8-91f8-4587-8ceb-35d44145aec0	2024-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211396 application number: ANDA211396
LYLLANA	ESTRADIOL	Amneal Pharmaceuticals LLC	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	2024-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211396 application number: ANDA211396 ndc (product): 65162-148

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4TI98Z838E	ESTRADIOL	50-28-2	ESTRADIOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
248478	estradiol 0.025 MG/Day Twice Weekly Transdermal System	PSN	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
241946	estradiol 0.0375 MG/Day Twice Weekly Transdermal System	PSN	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
242891	estradiol 0.05 MG/Day Twice Weekly Transdermal System	PSN	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
1149632	estradiol 0.075 MG/Day Twice Weekly Transdermal System	PSN	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
242892	estradiol 0.1 MG/Day Twice Weekly Transdermal System	PSN	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
2399892	Lyllana 0.025 MG/Day Twice Weekly Transdermal System	PSN	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
2399895	Lyllana 0.0375 MG/Day Twice Weekly Transdermal System	PSN	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
2399898	Lyllana 0.05 MG/Day Twice Weekly Transdermal System	PSN	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
2399901	Lyllana 0.075 MG/Day Twice Weekly Transdermal System	PSN	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
2399904	Lyllana 0.1 MG/Day Twice Weekly Transdermal System	PSN	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
2399892	84 HR estradiol 0.00104 MG/HR Transdermal System [Lyllana]	SBD	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
2399895	84 HR estradiol 0.00156 MG/HR Transdermal System [Lyllana]	SBD	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
2399898	84 HR estradiol 0.00208 MG/HR Transdermal System [Lyllana]	SBD	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
2399901	84 HR estradiol 0.00313 MG/HR Transdermal System [Lyllana]	SBD	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
2399904	84 HR estradiol 0.00417 MG/HR Transdermal System [Lyllana]	SBD	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
248478	84 HR estradiol 0.00104 MG/HR Transdermal System	SCD	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
241946	84 HR estradiol 0.00156 MG/HR Transdermal System	SCD	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
242891	84 HR estradiol 0.00208 MG/HR Transdermal System	SCD	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
1149632	84 HR estradiol 0.00313 MG/HR Transdermal System	SCD	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
242892	84 HR estradiol 0.00417 MG/HR Transdermal System	SCD	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
2399892	84 HR Lyllana 0.00104 MG/HR Transdermal System	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
2399895	84 HR Lyllana 0.00156 MG/HR Transdermal System	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
2399898	84 HR Lyllana 0.00208 MG/HR Transdermal System	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
2399901	84 HR Lyllana 0.00313 MG/HR Transdermal System	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
2399904	84 HR Lyllana 0.00417 MG/HR Transdermal System	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
248478	estradiol 0.00104 MG/HR 84 HR Transdermal Patch	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
241946	estradiol 0.00156 MG/HR 84 HR Transdermal Patch	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
242891	estradiol 0.00208 MG/HR 84 HR Transdermal Patch	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
1149632	estradiol 0.00313 MG/HR 84 HR Transdermal Patch	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
242892	estradiol 0.00417 MG/HR 84 HR Transdermal Patch	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
248478	estradiol 0.025 MG/Day Twice Weekly Transdermal Patch	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
248478	estradiol 0.025 MG/Day Twice Weekly Transdermal System	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
241946	estradiol 0.0375 MG/Day Twice Weekly Transdermal System	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
242891	estradiol 0.05 MG/Day Twice Weekly Transdermal System	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
1149632	estradiol 0.075 MG/Day Twice Weekly Transdermal System	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
242892	estradiol 0.1 MG/24HR Twice Weekly Transdermal Patch	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
242892	estradiol 0.1 MG/Day Twice Weekly Transdermal System	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
241946	estradiol 37.5 MCG/Day Twice Weekly Transdermal Patch	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
242891	estradiol 50 MCG/Day Twice Weekly Transdermal Patch	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
1149632	estradiol 75 MCG/Day Twice Weekly Transdermal Patch	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
2399892	Lyllana 0.025 MG/Day Twice Weekly Transdermal Patch	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
2399895	Lyllana 0.0375 MG/Day Twice Weekly Transdermal Patch	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
2399898	Lyllana 0.05 MG/Day Twice Weekly Transdermal Patch	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
2399901	Lyllana 0.075 MG/Day Twice Weekly Transdermal Patch	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15
2399904	Lyllana 0.1 MG/Day Twice Weekly Transdermal Patch	SY	09c472c6-a38a-4a3d-b048-6fefd52e2ad3	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-148-04	65162014804	1 d in 1 POUCH	1 d					Historical
65162-148-08	65162014808	8 POUCH in 1 CARTON (65162-148-08) / 1 d in 1 POUCH (65162-148-04)	8 pouch	2020-09-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LYLLANA - Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals, LLC	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals, LLC	2024-05-15	HUMAN PRESCRIPTION DRUG LABEL	15