Home NDC 0054-0829 Progesterone
Product NDC 0054-0829
11-digit product format 000540829
Labeler code 0054
Product ID 0054-0829_f38dd5d9-88b1-4792-bbb9-5f589d9539b0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Progesterone
Dosage form CAPSULE
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc
Application ANDA200456
Marketing category ANDA
Marketing start 2025-05-15
Substance PROGESTERONE
Active strength 100 mg/1
Pharmacologic classes Progesterone [CS], Progesterone [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 42 .
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 A200456-001 PROGESTERONE PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 A200456-002 PROGESTERONE PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 84 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 2026-08-18 06:07:40 2026-07 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL BX 2012-09-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL BX 2012-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL BX 2012-09-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL BX 2012-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL BX 2012-09-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL BX 2012-09-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2012-09-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2012-09-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL BX 2012-09-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL BX 2012-09-28 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Progesterone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROGESTERONE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4G7DS2Q64Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 260243 Internal RxNorm lookup 312641 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 0054-0829-25 Progesterone 100 in 1 BOTTLE CAPSULE 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0829 PROGESTERONE CAPSULE [HIKMA PHARMACEUTICALS USA INC] 1 Current NDC, 1 package rows 20250515_d8bcc439-c21d-4eeb-9159-f51e0c60bd70.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0054-0829-25 00054082925 100 CAPSULE in 1 BOTTLE (0054-0829-25) 100 capsule 2025-05-15 No No Current