Bonsity

Product NDC: 47781-852
11-digit product format: 477810852
Labeler code: 47781
Product ID: 47781-852_3da7691f-d4ab-4726-72e0-757ab0651148
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: teriparatide
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Alvogen Inc.
Application: NDA211939
Marketing category: NDA
Marketing start: 2025-06-06
Substance: TERIPARATIDE
Active strength: 250 ug/mL
Pharmacologic classes: Parathyroid Hormone Analog [EPC], Parathyroid Hormone [CS]
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 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
N211939-001	BONSITY	TERIPARATIDE	0.56MG/2.24ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS			2019-10-04

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N211939-001	BONSITY	0.56MG/2.24ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211939-001	BONSITY	0.56MG/2.24ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211939-001	BONSITY	0.56MG/2.24ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211939-001	BONSITY	0.56MG/2.24ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211939-001	BONSITY	0.62MG/2.48ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211939-001	BONSITY	0.56MG/2.24ML (0.25MG/ML)	SOLUTION / SUBCUTANEOUS	2019-10-04	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Bonsity
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TERIPARATIDE	250 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
10T9CSU89I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1435115	Internal RxNorm lookup
2716408	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2d0c89a2-3849-adf6-007d-aeca21cf417c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b921a6be-c897-e1d4-f6d7-f4df8c2a7a6a	Product name	2	20250731
bc54407b-4c2b-4714-a018-cf90828b0cb1	Product name	1	20250317
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
25117fd6-247a-42b6-bd01-89f9877d0f51	Product name	1	20200304
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
47781-852-89	Bonsity	2.24 mL in 1 SYRINGE	INJECTION, SOLUTION	2.24		1
47781-852-89	Bonsity	1 in 1 CARTON	INJECTION, SOLUTION	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47781-852-89	ML - Milliliter	47781-852	c828373e-5665-450c-a1f9-5676ae34feab	1	2025-06-13

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bonsity	TERIPARATIDE	Alvogen Inc.	2d0c89a2-3849-adf6-007d-aeca21cf417c	2025-06-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211939 application number: NDA211939 ndc (product): 47781-852
teriparatide	TERIPARATIDE	Alvogen, Inc.	1b007339-dd0d-f019-5e0a-9b1b0f75011c	2025-05-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211939 application number: NDA211939

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
10T9CSU89I	TERIPARATIDE	52232-67-4	TERIPARATIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2716408	BONSITY 20 MCG/Dose in 28 Dose Pen Injector	PSN	2d0c89a2-3849-adf6-007d-aeca21cf417c	1
1435115	teriparatide 20 MCG/Dose in 28 Dose Pen Injector	PSN	2d0c89a2-3849-adf6-007d-aeca21cf417c	1
2716408	28 ACTUAT teriparatide 0.02 MG/ACTUAT Pen Injector [Bonsity]	SBD	2d0c89a2-3849-adf6-007d-aeca21cf417c	1
1435115	28 ACTUAT teriparatide 0.02 MG/ACTUAT Pen Injector	SCD	2d0c89a2-3849-adf6-007d-aeca21cf417c	1
2716408	28 ACTUAT Bonsity 0.02 MG/ACTUAT Pen Injector	SY	2d0c89a2-3849-adf6-007d-aeca21cf417c	1
1435115	teriparatide 0.02 MG/ACTUAT Pen Injector, 28 ACTUAT	SY	2d0c89a2-3849-adf6-007d-aeca21cf417c	1
1435115	teriparatide 20 MCG/ACTUAT Pen Injector, 28 ACTUAT	SY	2d0c89a2-3849-adf6-007d-aeca21cf417c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
47781-852-89	47781085289	1 SYRINGE in 1 CARTON (47781-852-89) / 2.24 mL in 1 SYRINGE	1 syringe	2025-06-06	No	No	Current