CALCITONIN SALMON

Product NDC: 63629-2152
Requested package NDC: 63629-2152-1
11-digit product format: 636292152
Labeler code: 63629
Product ID: 63629-2152_c2317f7e-f964-4a2b-bea2-383188361c8c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CALCITONIN SALMON
Dosage form: SPRAY, METERED
Route: NASAL
Labeler: Bryant Ranch Prepack
Application: ANDA076979
Marketing category: ANDA
Marketing start: 2009-06-08
Marketing end: 0000-00-00
Substance: CALCITONIN SALMON
Active strength: 200 [iU]/.09mL
Pharmacologic classes: Calcitonin [CS], Calcitonin [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-2152	63629-2152-1	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A076979-001	CALCITONIN-SALMON	CALCITONIN SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB		2009-06-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A076979-001	AB

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL	AB	2009-06-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076979-001	CALCITONIN-SALMON	200 IU/SPRAY	SPRAY, METERED / NASAL		2009-06-08	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076979-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076979-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076979-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076979-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076979-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076979-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076979-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076979-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076979-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076979-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076979-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076979-001	AB	1	`79d66fd596c7…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076979-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076979-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076979-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076979-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076979-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076979-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076979-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076979-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076979-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076979-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076979-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076979-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076979-001	AB	1	`ea99ee380514…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076979-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076979-001	AB	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2152-1	ML - Milliliter	63629-2152	269dd410-1a02-405d-b728-e6c1b9021b3f	1	2021-05-05

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CALCITONIN SALMON	CALCITONIN SALMON	Par Health USA, LLC	a6eaedb3-5c96-4859-be43-a48c9c818bc7	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076979 application number: ANDA076979

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7SFC6U2VI5	CALCITONIN SALMON	47931-85-1	CALCITONIN SALMON

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2152-1	63629215201	30 mL in 1 BOTTLE, GLASS (63629-2152-1)	30 ml	2021-03-15	0000-00-00	No	No	Current