Home NDC 63629-8530 Progesterone
Product NDC 63629-8530
11-digit product format 636298530
Labeler code 63629
Product ID 63629-8530_8b25ee3e-4602-46fa-9db3-971c0d9ef023
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Progesterone
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application NDA019781
Marketing category NDA
Marketing start 2016-07-13
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 2023-12-31
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 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63629-8530-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63629-8530-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 63629-8530-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 63629-8530-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 63629-8530-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 63629-8530-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 63629-8530-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 63629-8530-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 63629-8530-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 63629-8530-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 63629-8530-1 367a005e9d99…383a685ebd0f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019781-001 PROMETRIUM PROGESTERONE 100MG CAPSULE / ORAL AB RLD 1998-05-14 N019781-002 PROMETRIUM PROGESTERONE 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 N019781-003 PROMETRIUM PROGESTERONE 300MG CAPSULE / ORAL 1999-10-15
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 4 · 123 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 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019781-002 PROMETRIUM 200MG CAPSULE / ORAL AB RLD, RS 1999-10-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019781-003 PROMETRIUM 300MG CAPSULE / ORAL 1999-10-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019781-001 PROMETRIUM 100MG CAPSULE / ORAL AB RLD 1998-05-14 8072bd15b7f6…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Prometrium PROGESTERONE Acertis Pharmaceuticals, LLC 1cf237ff-c4f8-4faa-a7aa-77599c856889 2026-07-23 Warnings, Adverse reactions Exact identifier application applno (NDA): 019781 application number: NDA019781
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-8530-1 63629853001 100 CAPSULE in 1 BOTTLE (63629-8530-1) 100 capsule 2021-05-19 0000-00-00 No No Current