Home NDC 68025-083 DIVIGEL
Product NDC 68025-083
11-digit product format 680250083
Labeler code 68025
Product ID 68025-083_077120b4-1172-49bc-b197-363f410589ab
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name estradiol
Dosage form GEL
Route TOPICAL
Labeler Vertical Pharmaceuticals, LLC
Application NDA022038
Marketing category NDA
Marketing start 2019-01-18
Substance ESTRADIOL
Active strength .75 mg/.75g
Pharmacologic classes Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [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 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022038-001 DIVIGEL ESTRADIOL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 N022038-002 DIVIGEL ESTRADIOL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 N022038-003 DIVIGEL ESTRADIOL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 N022038-004 DIVIGEL ESTRADIOL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2018-08-17 N022038-005 DIVIGEL ESTRADIOL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2019-12-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 · 94 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 N022038-001 DIVIGEL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022038-002 DIVIGEL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022038-003 DIVIGEL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022038-004 DIVIGEL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2018-08-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022038-005 DIVIGEL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2019-12-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022038-001 DIVIGEL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022038-002 DIVIGEL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022038-003 DIVIGEL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022038-004 DIVIGEL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2018-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022038-005 DIVIGEL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2019-12-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022038-001 DIVIGEL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022038-002 DIVIGEL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022038-003 DIVIGEL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022038-004 DIVIGEL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2018-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022038-005 DIVIGEL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2019-12-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022038-001 DIVIGEL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022038-002 DIVIGEL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022038-003 DIVIGEL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022038-004 DIVIGEL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2018-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022038-005 DIVIGEL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2019-12-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022038-001 DIVIGEL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022038-002 DIVIGEL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022038-003 DIVIGEL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022038-004 DIVIGEL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2018-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022038-005 DIVIGEL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2019-12-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022038-001 DIVIGEL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022038-002 DIVIGEL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022038-003 DIVIGEL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022038-004 DIVIGEL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2018-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022038-005 DIVIGEL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2019-12-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022038-001 DIVIGEL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022038-002 DIVIGEL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022038-003 DIVIGEL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022038-004 DIVIGEL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2018-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022038-005 DIVIGEL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2019-12-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022038-001 DIVIGEL 0.1% (0.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022038-002 DIVIGEL 0.1% (0.5GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022038-003 DIVIGEL 0.1% (1GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2007-06-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022038-004 DIVIGEL 0.1% (0.75GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2018-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022038-005 DIVIGEL 0.1% (1.25GM/PACKET) GEL / TRANSDERMAL AB RLD, RS 2019-12-12 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
Additional Listing Data#
Finished product Yes
Brand name base DIVIGEL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTRADIOL .75 mg/.75g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4TI98Z838E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2619677 Internal RxNorm lookup 2619678 Internal RxNorm lookup 2619679 Internal RxNorm lookup 2619680 Internal RxNorm lookup 2619681 Internal RxNorm lookup 2619682 Internal RxNorm lookup 2619683 Internal RxNorm lookup 2619684 Internal RxNorm lookup 2619685 Internal RxNorm lookup 2619686 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Estradiol ACTIVE INGREDIENT 4TI98Z838E DIVIGEL (ESTRADIOL) GEL [VERTICAL PHARMACEUTICALS, LLC] 2 Estradiol ACTIVE MOIETY 4TI98Z838E DIVIGEL (ESTRADIOL) GEL [VERTICAL PHARMACEUTICALS, LLC] 2 alcohol INACTIVE INGREDIENT 3K9958V90M DIVIGEL (ESTRADIOL) GEL [VERTICAL PHARMACEUTICALS, LLC] 2 carbomer homopolymer type b (allyl pentaerythritol crosslinked) INACTIVE INGREDIENT HHT01ZNK31 DIVIGEL (ESTRADIOL) GEL [VERTICAL PHARMACEUTICALS, LLC] 2 carbomer homopolymer type c (allyl pentaerythritol crosslinked) INACTIVE INGREDIENT 4Q93RCW27E DIVIGEL (ESTRADIOL) GEL [VERTICAL PHARMACEUTICALS, LLC] 2 Propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 DIVIGEL (ESTRADIOL) GEL [VERTICAL PHARMACEUTICALS, LLC] 2 trolamine INACTIVE INGREDIENT 9O3K93S3TK DIVIGEL (ESTRADIOL) GEL [VERTICAL PHARMACEUTICALS, LLC] 2 water INACTIVE INGREDIENT 059QF0KO0R DIVIGEL (ESTRADIOL) GEL [VERTICAL PHARMACEUTICALS, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68025-083 DIVIGEL (ESTRADIOL) GEL [VERTICAL PHARMACEUTICALS, LLC] 30 Current NDC, Legacy NDC, 4 package rows 20240725_59e610dc-883e-4f07-9ec6-a5841b0bf9fb.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 · 2 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2619678 Divigel 0.1 % (0.25MG / 0.25GM) Transdermal Gel PSN 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619680 Divigel 0.1 % (0.5MG / 0.5GM) Transdermal Gel PSN 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619682 Divigel 0.1 % (0.75MG / 0.75GM) Transdermal Gel PSN 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619686 Divigel 0.1 % (1.25MG / 1.25GM) Transdermal Gel PSN 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619684 Divigel 0.1 % (1MG / 1GM) Transdermal Gel PSN 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619677 estradiol 0.1 % (0.25MG / 0.25GM) Transdermal Gel PSN 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619679 estradiol 0.1 % (0.5MG / 0.5GM) Transdermal Gel PSN 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619681 estradiol 0.1 % (0.75MG / 0.75GM) Transdermal Gel PSN 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619685 estradiol 0.1 % (1.25MG / 1.25GM) Transdermal Gel PSN 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619683 estradiol 0.1 % (1MG / 1GM) Transdermal Gel PSN 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619684 1000 MG estradiol 0.001 MG/MG Topical Gel [Divigel] SBD 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619686 1250 MG estradiol 0.001 MG/MG Topical Gel [Divigel] SBD 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619678 250 MG estradiol 0.001 MG/MG Topical Gel [Divigel] SBD 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619680 500 MG estradiol 0.001 MG/MG Topical Gel [Divigel] SBD 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619682 750 MG estradiol 0.001 MG/MG Topical Gel [Divigel] SBD 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619683 1000 MG estradiol 0.001 MG/MG Topical Gel SCD 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619685 1250 MG estradiol 0.001 MG/MG Topical Gel SCD 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619677 250 MG estradiol 0.001 MG/MG Topical Gel SCD 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619679 500 MG estradiol 0.001 MG/MG Topical Gel SCD 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619681 750 MG estradiol 0.001 MG/MG Topical Gel SCD 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619684 1000 MG Divigel 0.001 MG/MG Topical Gel SY 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619686 1250 MG Divigel 0.001 MG/MG Topical Gel SY 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619678 250 MG Divigel 0.001 MG/MG Topical Gel SY 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619680 500 MG Divigel 0.001 MG/MG Topical Gel SY 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619682 750 MG Divigel 0.001 MG/MG Topical Gel SY 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619678 Divigel 0.1 % Transdermal Gel, 0.25 GM SY 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619680 Divigel 0.1 % Transdermal Gel, 0.5 GM SY 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619682 Divigel 0.1 % Transdermal Gel, 0.75 GM SY 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619684 Divigel 0.1 % Transdermal Gel, 1 GM SY 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619686 Divigel 0.1 % Transdermal Gel, 1.25 GM SY 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619677 estradiol 0.1 % Transdermal Gel, 0.25 GM SY 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619679 estradiol 0.1 % Transdermal Gel, 0.5 GM SY 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619681 estradiol 0.1 % Transdermal Gel, 0.75 GM SY 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619683 estradiol 0.1 % Transdermal Gel, 1 GM SY 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31 2619685 estradiol 0.1 % Transdermal Gel, 1.25 GM SY 59e610dc-883e-4f07-9ec6-a5841b0bf9fb 31
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68025-083-07 68025008307 7 PACKET in 1 CARTON (68025-083-07) / .75 g in 1 PACKET 7 packet 2019-01-18 0000-00-00 Yes No Current 68025-083-30 68025008330 30 PACKET in 1 CARTON (68025-083-30) / .75 g in 1 PACKET 30 packet 2019-01-18 0000-00-00 No No Current