Home NDC 76420-071-10 Progesterone
Product NDC 76420-071
Requested package NDC 76420-071-10
11-digit product format 764200071
Labeler code 76420
Product ID 76420-071_9a710009-a90f-095c-e053-2a95a90a1857
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Progesterone
Dosage form CAPSULE
Route ORAL
Labeler Asclemed USA, Inc.
Application ANDA200456
Marketing category ANDA
Marketing start 2012-10-04
Marketing end 0000-00-00
Substance PROGESTERONE
Active strength 200 mg/1
Pharmacologic classes Progesterone [CS],Progesterone [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 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 · 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 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…2021-12-28 21:50 UTC 2021-12 A200456-001 PROGESTERONE 100MG CAPSULE / ORAL BX 2012-09-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A200456-002 PROGESTERONE 200MG CAPSULE / ORAL BX 2012-09-28 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76420-071-10 76420007110 100 CAPSULE in 1 BOTTLE, PLASTIC (76420-071-10) 100 capsule 2019-12-24 0000-00-00 No No Current