Home NDC 0013-1042 Estring
Product NDC 0013-1042
11-digit product format 000131042
Labeler code 0013
Product ID 0013-1042_a7184faa-345a-46c5-82b5-badd9887a6e9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name estradiol
Dosage form SYSTEM
Route VAGINAL
Labeler Pfizer Laboratories Div Pfizer Inc
Application NDA020472
Marketing category NDA
Marketing start 2023-06-05
Substance ESTRADIOL
Active strength 2 mg/1
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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020472-001 ESTRING ESTRADIOL 0.0075MG/24HR INSERT, EXTENDED RELEASE / VAGINAL RLD, RS 1996-04-26
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.
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 2026-08-01 22:54:32 2026-06 N020472-001 ESTRING 0.0075MG/24HR INSERT, EXTENDED RELEASE / VAGINAL RLD, RS 1996-04-26 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Estring
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESTRADIOL 2 mg/1
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 848328 Internal RxNorm lookup 848330 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 0013-1042-01 Estring 1 in 1 POUCH SYSTEM 1 7 0013-1042-01 Estring 1 in 1 CARTON SYSTEM 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0013-1042 ESTRING (ESTRADIOL) SYSTEM [PFIZER LABORATORIES DIV PFIZER INC] 5 Current NDC, 2 package rows 20250523_110b9865-5a07-4d45-b560-e89947f12600.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0013-1042-01 00013104201 1 POUCH in 1 CARTON (0013-1042-01) / 1 SYSTEM in 1 POUCH 1 pouch 2023-06-05 No No Current