Home NDC 63629-7475-1 Progesterone
Product NDC 63629-7475
Requested package NDC 63629-7475-1
11-digit product format 636297475
Labeler code 63629
Product ID 63629-7475_9d59c07f-5b16-4a33-9080-db0587988d7e
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 2021-12-31
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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63629-7475 63629-7475-1 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63629-7475 63629-7475-1 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 63629-7475 63629-7475-1 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…
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.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-7475-1 2020-06-14 Progesterone, USP 63629-7475-2 2020-06-14 Progesterone, USP 63629-7475-3 2020-06-14 Progesterone, USP 63629-7475-4 2020-06-14 Progesterone, USP 63629-7475-5 2020-06-14 Progesterone, USP 63629-7475-1 2020-01-31 Progesterone, USP 63629-7475-2 2020-01-31 Progesterone, USP 63629-7475-3 2020-01-31 Progesterone, USP 63629-7475-4 2020-01-31 Progesterone, USP 63629-7475-5 2020-01-31 Progesterone, USP
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-7475 PROGESTERONE CAPSULE [BRYANT RANCH PREPACK] 7 Legacy NDC 20241220_424d72fe-3ac2-4d19-b687-734588a744ed.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 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 63629-7475-1 63629747501 30 CAPSULE in 1 BOTTLE (63629-7475-1) 30 capsule 2017-11-27 0000-00-00 No No Current