Home NDC 25021-473 Calcitonin Salmon
Product NDC 25021-473
11-digit product format 250210473
Labeler code 25021
Product ID 25021-473_787c3f6a-788e-448f-b3ec-4541890f22fa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcitonin Salmon
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; SUBCUTANEOUS
Labeler Sagent Pharmaceuticals
Application ANDA219196
Marketing category ANDA
Marketing start 2025-09-15
Substance CALCITONIN SALMON
Active strength 400 [USP'U]/2mL
Pharmacologic classes Calcitonin [CS], Calcitonin [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219196-001 CALCITONIN-SALMON CALCITONIN SALMON 200 IU/ML INJECTABLE / INJECTION AP 2025-07-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219196-001 AP
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 2026-08-18 06:07:40 2026-07 A219196-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2025-07-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219196-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2025-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219196-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2025-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A219196-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2025-07-09 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219196-001 CALCITONIN-SALMON 200 IU/ML INJECTABLE / INJECTION AP 2025-07-09 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Calcitonin Salmon
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCITONIN SALMON 400 [USP'U]/2mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7SFC6U2VI5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308866 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 25021-473-02 Calcitonin Salmon 1 in 1 CARTON INJECTION, SOLUTION 1 5 25021-473-02 Calcitonin Salmon 2 mL in 1 VIAL INJECTION, SOLUTION 2 5
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 Sample Exclude flag Status 25021-473-02 25021047302 1 VIAL in 1 CARTON (25021-473-02) / 2 mL in 1 VIAL 1 vial 2025-09-15 No No Current