Home NDC 60429-868-01 Progesterone
Product NDC 60429-868
Requested package NDC 60429-868-01
11-digit product format 604290868
Labeler code 60429
Product ID 60429-868_99732e67-0219-2b16-e053-2995a90a0916
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Progesterone
Dosage form CAPSULE
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA208801
Marketing category ANDA
Marketing start 2017-02-28
Marketing end 0000-00-00
Substance PROGESTERONE
Active strength 100 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 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 A208801-001 PROGESTERONE PROGESTERONE 100MG CAPSULE / ORAL AB 2017-02-28 A208801-002 PROGESTERONE PROGESTERONE 200MG CAPSULE / ORAL AB 2017-02-28
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 A208801-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2017-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208801-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2017-02-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208801-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2017-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208801-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2017-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208801-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2017-02-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208801-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2017-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208801-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2017-02-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208801-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2017-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208801-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2017-02-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208801-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2017-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208801-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2017-02-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208801-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2017-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208801-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2017-02-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208801-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2017-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208801-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2017-02-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208801-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2017-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208801-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2017-02-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208801-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2017-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208801-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2017-02-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208801-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2017-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208801-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2017-02-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208801-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2017-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208801-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2017-02-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208801-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2017-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208801-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2017-02-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208801-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2017-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208801-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2017-02-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208801-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2017-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208801-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2017-02-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208801-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2017-02-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208801-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2017-02-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208801-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2017-02-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208801-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2017-02-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208801-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2017-02-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208801-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2017-02-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208801-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2017-02-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208801-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2017-02-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A208801-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2017-02-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208801-001 PROGESTERONE 100MG CAPSULE / ORAL AB 2017-02-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A208801-002 PROGESTERONE 200MG CAPSULE / ORAL AB 2017-02-28 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 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 Progesterone PROGESTERONE Dr. Reddys Laboratories, Inc. efded380-02ff-68c9-13e4-47a561ede440 2024-03-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208801 application number: ANDA208801
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60429-868-01 60429086801 100 CAPSULE in 1 BOTTLE (60429-868-01) 100 capsule 2017-04-05 0000-00-00 No No Current