Home NDC 50419-482 Angeliq
Product NDC 50419-482
11-digit product format 504190482
Labeler code 50419
Product ID 50419-482_261d4ace-5c4e-48f6-b793-354492017e89
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name drospirenone and estradiol
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bayer HealthCare Pharmaceuticals Inc.
Application NDA021355
Marketing category NDA
Marketing start 2012-02-29
Substance DROSPIRENONE; ESTRADIOL
Active strength .25; .5 mg/1; mg/1
Pharmacologic classes Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021355-001 ANGELIQ DROSPIRENONE; ESTRADIOL 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 N021355-002 ANGELIQ DROSPIRENONE; ESTRADIOL 0.5MG;1MG TABLET / ORAL AB RLD, RS 2005-09-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021355-002 AB
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021355-001 8906890 2031-10-22 Drug product 2015-01-08
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 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL AB RLD, RS 2005-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL AB RLD, RS 2005-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021355-001 ANGELIQ 0.25MG;0.5MG TABLET / ORAL RLD 2012-02-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021355-002 ANGELIQ 0.5MG;1MG TABLET / ORAL RLD, RS 2005-09-28 782e0a99824c…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021355-002 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021355-002 AB 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021355-002 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 41 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 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021355-001 8906890 2031-10-22 Drug product 2015-01-08 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Angeliq
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTRADIOL .25 mg/1 DROSPIRENONE .5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N295J34A25 Internal UNII lookup 4TI98Z838E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1483549 Internal RxNorm lookup 1483550 Internal RxNorm lookup 1483551 Internal RxNorm lookup 1483552 Internal RxNorm lookup 1483553 Internal RxNorm lookup 1483554 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50419-482-01 Angeliq 28 in 1 BLISTER PACK TABLET, FILM COATED 28 20 50419-482-03 Angeliq 3 in 1 CARTON TABLET, FILM COATED 3 20 50419-482-71 Angeliq 14 in 1 BLISTER PACK TABLET, FILM COATED 14 20 50419-482-72 Angeliq 1 in 1 CARTON TABLET, FILM COATED 1 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DROSPIRENONE ACTIVE INGREDIENT N295J34A25 ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 7 ESTRADIOL ACTIVE INGREDIENT 4TI98Z838E ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 7 DROSPIRENONE ACTIVE MOIETY N295J34A25 ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 7 ESTRADIOL ACTIVE MOIETY 4TI98Z838E ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 7 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 7 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 7 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 7 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 7 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 7 POVIDONE K25 INACTIVE INGREDIENT K0KQV10C35 ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 7 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 7 TALC INACTIVE INGREDIENT 7SEV7J4R1U ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50419-482 ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.] 17 Current NDC, Legacy NDC, 4 package rows 20240207_761834c2-6b61-4583-84c2-f1ca4a97c4f2.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Angeliq DROSPIRENONE AND ESTRADIOL Bayer HealthCare Pharmaceuticals Inc. 761834c2-6b61-4583-84c2-f1ca4a97c4f2 2026-03-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021355 application number: NDA021355 ndc (product): 50419-482
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50419-482-01 50419048201 28 in 1 BLISTER PACK Historical 50419-482-03 50419048203 3 BLISTER PACK in 1 CARTON (50419-482-03) / 28 TABLET, FILM COATED in 1 BLISTER PACK (50419-482-01) 3 blister pack 2012-02-29 0000-00-00 No No Current 50419-482-71 50419048271 14 in 1 BLISTER PACK Historical 50419-482-72 50419048272 1 BLISTER PACK in 1 CARTON (50419-482-72) / 14 TABLET, FILM COATED in 1 BLISTER PACK (50419-482-71) 1 blister pack 2012-02-29 0000-00-00 No No Current