Home NDC 67457-675 Miacalcin
Product NDC 67457-675
11-digit product format 674570675
Labeler code 67457
Product ID 67457-675_ebb1716e-a4f1-42c4-82ac-ba5c062cfba0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name calcitonin salmon
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; SUBCUTANEOUS
Labeler Mylan Institutional LLC
Application NDA017808
Marketing category NDA
Marketing start 2016-09-16
Substance CALCITONIN SALMON
Active strength 200 [USP'U]/mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N017808-001 MIACALCIN CALCITONIN SALMON 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1986-07-03 N017808-002 MIACALCIN CALCITONIN SALMON 200 IU/ML INJECTABLE / INJECTION AP RLD, RS 1991-03-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N017808-002 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.
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 N017808-001 MIACALCIN 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1986-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N017808-002 MIACALCIN 200 IU/ML INJECTABLE / INJECTION AP RLD, RS 1991-03-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N017808-001 MIACALCIN 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1986-07-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N017808-002 MIACALCIN 200 IU/ML INJECTABLE / INJECTION AP RLD, RS 1991-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017808-001 MIACALCIN 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1986-07-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N017808-002 MIACALCIN 200 IU/ML INJECTABLE / INJECTION AP RLD, RS 1991-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N017808-001 MIACALCIN 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1986-07-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N017808-002 MIACALCIN 200 IU/ML INJECTABLE / INJECTION AP RLD, RS 1991-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017808-001 MIACALCIN 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1986-07-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N017808-002 MIACALCIN 200 IU/ML INJECTABLE / INJECTION AP RLD, RS 1991-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017808-001 MIACALCIN 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1986-07-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N017808-002 MIACALCIN 200 IU/ML INJECTABLE / INJECTION AP RLD, RS 1991-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017808-001 MIACALCIN 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1986-07-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N017808-002 MIACALCIN 200 IU/ML INJECTABLE / INJECTION AP RLD, RS 1991-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017808-001 MIACALCIN 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1986-07-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N017808-002 MIACALCIN 200 IU/ML INJECTABLE / INJECTION AP RLD, RS 1991-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017808-001 MIACALCIN 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1986-07-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N017808-002 MIACALCIN 200 IU/ML INJECTABLE / INJECTION AP RLD, RS 1991-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017808-001 MIACALCIN 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1986-07-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N017808-002 MIACALCIN 200 IU/ML INJECTABLE / INJECTION AP RLD, RS 1991-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N017808-001 MIACALCIN 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1986-07-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N017808-002 MIACALCIN 200 IU/ML INJECTABLE / INJECTION AP RLD, RS 1991-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017808-001 MIACALCIN 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1986-07-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N017808-002 MIACALCIN 200 IU/ML INJECTABLE / INJECTION AP RLD, RS 1991-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017808-001 MIACALCIN 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1986-07-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N017808-002 MIACALCIN 200 IU/ML INJECTABLE / INJECTION AP RLD, RS 1991-03-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017808-001 MIACALCIN 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1986-07-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N017808-002 MIACALCIN 200 IU/ML INJECTABLE / INJECTION AP RLD, RS 1991-03-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N017808-001 MIACALCIN 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1986-07-03 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N017808-002 MIACALCIN 200 IU/ML INJECTABLE / INJECTION AP RLD, RS 1991-03-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N017808-001 MIACALCIN 100 IU/ML INJECTABLE / INJECTION RLD 1986-07-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N017808-002 MIACALCIN 200 IU/ML INJECTABLE / INJECTION AP RLD, RS 1991-03-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N017808-001 MIACALCIN 100 IU/ML INJECTABLE / INJECTION RLD 1986-07-03 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N017808-002 MIACALCIN 200 IU/ML INJECTABLE / INJECTION AP RLD, RS 1991-03-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N017808-001 MIACALCIN 100 IU/ML INJECTABLE / INJECTION RLD 1986-07-03 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N017808-002 MIACALCIN 200 IU/ML INJECTABLE / INJECTION AP RLD, RS 1991-03-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N017808-001 MIACALCIN 100 IU/ML INJECTABLE / INJECTION RLD 1986-07-03 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N017808-002 MIACALCIN 200 IU/ML INJECTABLE / INJECTION RLD, RS 1991-03-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N017808-001 MIACALCIN 100 IU/ML INJECTABLE / INJECTION RLD 1986-07-03 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N017808-002 MIACALCIN 200 IU/ML INJECTABLE / INJECTION AP RLD, RS 1991-03-29 bb7c543d1eb4…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Miacalcin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CALCITONIN SALMON 200 [USP'U]/mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 213570 Internal RxNorm lookup 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 67457-675-02 Miacalcin 1 in 1 CARTON INJECTION, SOLUTION 1 8 67457-675-02 Miacalcin 2 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 2 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-675 MIACALCIN (CALCITONIN SALMON) INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] 7 Current NDC, Legacy NDC, 2 package rows 20240913_89cd4f46-b88a-4c10-b25c-47352280dc4e.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 67457-675-02 67457067502 1 VIAL, MULTI-DOSE in 1 CARTON (67457-675-02) / 2 mL in 1 VIAL, MULTI-DOSE 2016-09-16 0000-00-00 No No Current