BYNFEZIA Pen
- Product NDC
- 62756-452
- 11-digit product format
- 627560452
- Labeler code
- 62756
- Product ID
- 62756-452_ee3c8bae-88f0-4b76-80af-98a3e3312585
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- octreotide acetate
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- NDA213224
- Marketing category
- NDA
- Marketing start
- 2025-02-24
- Substance
- OCTREOTIDE ACETATE
- Active strength
- 2.5 mg/mL
- Pharmacologic classes
- Somatostatin Analog [EPC], Somatostatin Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 62756-452-37 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 62756-452-36 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 62756-452-37 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 62756-452-36 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 62756-452-37 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 62756-452-36 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 62756-452-37 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 62756-452-36 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 62756-452-37 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 62756-452-36 | 367a005e9d99… | 383a685ebd0f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N213224-001 | BYNFEZIA PEN | OCTREOTIDE ACETATE | EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2024-09-27 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N213224-001 | 10342850 | 2038-05-15 | Drug product | 2024-10-18 | |
| N213224-001 | 11052196 | 2040-11-03 | U-4007 | 2024-10-18 | |
| N213224-001 | 11052196 | 2040-11-03 | U-4008 | 2024-10-18 | |
| N213224-001 | 11052196 | 2040-11-03 | U-4009 | 2024-10-18 | |
| N213224-001 | 11246991 | 2040-11-03 | U-4007 | 2024-10-18 | |
| N213224-001 | 11246991 | 2040-11-03 | U-4008 | 2024-10-18 | |
| N213224-001 | 11246991 | 2040-11-03 | U-4009 | 2024-10-18 | |
| N213224-001 | 11534553 | 2040-11-03 | U-4007 | 2024-10-18 | |
| N213224-001 | 11534553 | 2040-11-03 | U-4008 | 2024-10-18 | |
| N213224-001 | 11534553 | 2040-11-03 | U-4009 | 2024-10-18 | |
| N213224-001 | 12350475 | 2041-12-29 | U-4007 | 2025-07-23 | |
| N213224-001 | 12350475 | 2041-12-29 | U-4008 | 2025-07-23 | |
| N213224-001 | 12350475 | 2041-12-29 | U-4009 | 2025-07-23 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N213224-001 | BYNFEZIA PEN | EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2024-09-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N213224-001 | BYNFEZIA PEN | EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2024-09-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213224-001 | BYNFEZIA PEN | EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2024-09-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213224-001 | BYNFEZIA PEN | EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2024-09-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N213224-001 | BYNFEZIA PEN | EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2024-09-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N213224-001 | BYNFEZIA PEN | EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2024-09-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N213224-001 | BYNFEZIA PEN | EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2024-09-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N213224-001 | BYNFEZIA PEN | EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2024-09-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N213224-001 | BYNFEZIA PEN | EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2024-09-27 | 2680178bc6a6… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N213224-001 | BYNFEZIA PEN | 7MG/2.8ML (2.5MG/ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2024-09-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N213224-001 | BYNFEZIA PEN | 7MG/2.8ML (2.5MG/ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2024-09-27 | d06236e962d9… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N213224-001 | BYNFEZIA PEN | EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2020-01-28 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N213224-001 | BYNFEZIA PEN | EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2020-01-28 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N213224-001 | BYNFEZIA PEN | EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2020-01-28 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N213224-001 | BYNFEZIA PEN | EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2020-01-28 | c0c555d07b60… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N213224-001 | BYNFEZIA PEN | EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) | SOLUTION / SUBCUTANEOUS | RLD, RS | 2024-09-27 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N213224-001 | 10342850 | 2038-05-15 | Drug product | 2024-10-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213224-001 | 11052196 | 2040-11-03 | U-4007 | 2024-10-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213224-001 | 11052196 | 2040-11-03 | U-4008 | 2024-10-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213224-001 | 11052196 | 2040-11-03 | U-4009 | 2024-10-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213224-001 | 11246991 | 2040-11-03 | U-4007 | 2024-10-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213224-001 | 11246991 | 2040-11-03 | U-4008 | 2024-10-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213224-001 | 11246991 | 2040-11-03 | U-4009 | 2024-10-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213224-001 | 11534553 | 2040-11-03 | U-4007 | 2024-10-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213224-001 | 11534553 | 2040-11-03 | U-4008 | 2024-10-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213224-001 | 11534553 | 2040-11-03 | U-4009 | 2024-10-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213224-001 | 12350475 | 2041-12-29 | U-4007 | 2025-07-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213224-001 | 12350475 | 2041-12-29 | U-4008 | 2025-07-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N213224-001 | 12350475 | 2041-12-29 | U-4009 | 2025-07-23 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N213224-001 | 10342850 | 2038-05-15 | Drug product | 2024-10-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213224-001 | 11052196 | 2040-11-03 | U-4007 | 2024-10-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213224-001 | 11052196 | 2040-11-03 | U-4008 | 2024-10-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213224-001 | 11052196 | 2040-11-03 | U-4009 | 2024-10-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213224-001 | 11246991 | 2040-11-03 | U-4007 | 2024-10-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213224-001 | 11246991 | 2040-11-03 | U-4008 | 2024-10-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213224-001 | 11246991 | 2040-11-03 | U-4009 | 2024-10-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213224-001 | 11534553 | 2040-11-03 | U-4007 | 2024-10-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213224-001 | 11534553 | 2040-11-03 | U-4008 | 2024-10-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213224-001 | 11534553 | 2040-11-03 | U-4009 | 2024-10-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213224-001 | 12350475 | 2041-12-29 | U-4007 | 2025-07-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213224-001 | 12350475 | 2041-12-29 | U-4008 | 2025-07-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N213224-001 | 12350475 | 2041-12-29 | U-4009 | 2025-07-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213224-001 | 10342850 | 2038-05-15 | Drug product | 2024-10-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213224-001 | 11052196 | 2040-11-03 | U-4007 | 2024-10-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213224-001 | 11052196 | 2040-11-03 | U-4008 | 2024-10-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213224-001 | 11052196 | 2040-11-03 | U-4009 | 2024-10-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213224-001 | 11246991 | 2040-11-03 | U-4007 | 2024-10-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213224-001 | 11246991 | 2040-11-03 | U-4008 | 2024-10-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213224-001 | 11246991 | 2040-11-03 | U-4009 | 2024-10-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213224-001 | 11534553 | 2040-11-03 | U-4007 | 2024-10-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213224-001 | 11534553 | 2040-11-03 | U-4008 | 2024-10-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213224-001 | 11534553 | 2040-11-03 | U-4009 | 2024-10-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213224-001 | 12350475 | 2041-12-29 | U-4007 | 2025-07-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213224-001 | 12350475 | 2041-12-29 | U-4008 | 2025-07-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N213224-001 | 12350475 | 2041-12-29 | U-4009 | 2025-07-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N213224-001 | 10342850 | 2038-05-15 | Drug product | 2024-10-18 | 31067a03dcf5… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BYNFEZIA Pen
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OCTREOTIDE ACETATE | 2.5 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 75R0U2568I | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 20ed4e79-ad4c-426f-859d-83790c00439b | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 62756-452-36 | BYNFEZIA Pen | 2.8 mL in 1 CARTRIDGE | INJECTION | 2.8 | 5 | |
| 62756-452-36 | BYNFEZIA Pen | 1 in 1 CARTON | INJECTION | 1 | 5 | |
| 62756-452-37 | BYNFEZIA Pen | 2 in 1 CARTON | INJECTION | 2 | 5 | |
| 62756-452-37 | BYNFEZIA Pen | 2.8 mL in 1 CARTRIDGE | INJECTION | 2.8 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 62756-452-36 | ML - Milliliter | 62756-452 | e8172a04-8a00-4086-a324-c9feed1765df | 1 | 2020-06-05 |
| 62756-452-37 | ML - Milliliter | 62756-452 | 481af9c4-1d97-4e50-a0cf-1c03a3605fb8 | 1 | 2024-12-10 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| BYNFEZIA Pen | OCTREOTIDE ACETATE | Sun Pharmaceutical Industries, Inc. | 20ed4e79-ad4c-426f-859d-83790c00439b | 2025-02-21 | Warnings, Adverse reactions | 213224 NDA213224 62756-452 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2360548 | Bynfezia 2500 MCG/ML in 2.8 ML Pen Injector | PSN | 20ed4e79-ad4c-426f-859d-83790c00439b | 5 |
| 2360543 | octreotide 2500 MCG/ML in 2.8 ML Pen Injector | PSN | 20ed4e79-ad4c-426f-859d-83790c00439b | 5 |
| 2360548 | 2.8 ML octreotide 2.5 MG/ML Pen Injector [Bynfezia] | SBD | 20ed4e79-ad4c-426f-859d-83790c00439b | 5 |
| 2360543 | 2.8 ML octreotide 2.5 MG/ML Pen Injector | SCD | 20ed4e79-ad4c-426f-859d-83790c00439b | 5 |
| 2360548 | Bynfezia 2.5 MG/ML per 2.8 ML Pen Injector | SY | 20ed4e79-ad4c-426f-859d-83790c00439b | 5 |
| 2360548 | Bynfezia 2500 MCG/ML per 2.8 ML Pen Injector | SY | 20ed4e79-ad4c-426f-859d-83790c00439b | 5 |
| 2360543 | octreotide (as octreotide acetate) 2.5 MG/ML per 2.8 ML Pen Injector | SY | 20ed4e79-ad4c-426f-859d-83790c00439b | 5 |
| 2360543 | octreotide (as octreotide acetate) 2500 MCG/ML per 2.8 ML Pen Injector | SY | 20ed4e79-ad4c-426f-859d-83790c00439b | 5 |
| 2360543 | octreotide (as octreotide acetate) 7000 MCG per 2.8 ML Pen Injector | SY | 20ed4e79-ad4c-426f-859d-83790c00439b | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 62756-452-36 | 62756045236 | 1 CARTRIDGE in 1 CARTON (62756-452-36) / 2.8 mL in 1 CARTRIDGE | 1 cartridge | 2025-02-24 | 0000-00-00 | No | No | Current |
| 62756-452-37 | 62756045237 | 2 CARTRIDGE in 1 CARTON (62756-452-37) / 2.8 mL in 1 CARTRIDGE | 2 cartridge | 2025-02-24 | 0000-00-00 | No | No | Current |