Home NDC 72989-372 Prometrium
Product NDC 72989-372
11-digit product format 729890372
Labeler code 72989
Product ID 72989-372_3d2fed08-88a5-4645-b158-33527a2556eb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Progesterone
Dosage form CAPSULE
Route ORAL
Labeler Acertis Pharmaceuticals, LLC
Application NDA019781
Marketing category NDA
Marketing start 2022-11-01
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 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.
Additional Listing Data#
Finished product Yes
Brand name base Prometrium
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 260243 Internal RxNorm lookup 261319 Internal RxNorm lookup 262080 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 72989-372-30 Prometrium 30 in 1 BOTTLE CAPSULE 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72989-372 PROMETRIUM (PROGESTERONE) CAPSULE [ACERTIS PHARMACEUTICALS, LLC] 2 Current NDC, Legacy NDC, 1 package rows 20240312_1cf237ff-c4f8-4faa-a7aa-77599c856889.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 Marketing end Sample Exclude flag Status 72989-372-30 72989037230 30 CAPSULE in 1 BOTTLE (72989-372-30) 30 capsule 2022-11-01 0000-00-00 No No Current