American Cockroach
- Product NDC
- 49288-0150
- 11-digit product format
- 492880150
- Labeler code
- 49288
- Product ID
- 49288-0150_0c2a583c-28b8-4184-9f4d-9feba1e683c9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- American Cockroach
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRADERMAL; SUBCUTANEOUS
- Labeler
- Antigen Laboratories, Inc.
- Application
- BLA102223
- Marketing category
- BLA
- Marketing start
- 1974-03-23
- Marketing end
- 0000-00-00
- Substance
- PERIPLANETA AMERICANA
- Active strength
- 0 g/mL
- Pharmacologic classes
- Non-Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Insect Proteins [CS],Allergens [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 49288-0150 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 49288-0150 | 49288-0150-1 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 49288-0150 | 49288-0150-2 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 49288-0150 | 49288-0150-3 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 49288-0150 | 49288-0150-4 | I | Inactivated by FDA | 2026-08-17 | |
| excluded package | package | 49288-0150 | 49288-0150-5 | I | Inactivated by FDA | 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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 49288-0150-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 49288-0150-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 49288-0150-5 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 49288-0150-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 49288-0150-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 49288-0150-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 49288-0150-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 49288-0150-5 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 49288-0150-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 49288-0150-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 49288-0150-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 49288-0150-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 49288-0150-5 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 49288-0150-4 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 49288-0150-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 49288-0150-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 49288-0150-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 49288-0150-5 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 49288-0150-4 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 49288-0150-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 49288-0150-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 49288-0150-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 49288-0150-5 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 49288-0150-4 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 49288-0150-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 49288-0150-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 49288-0150-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 49288-0150-5 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 49288-0150-4 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 49288-0150-2 | cdf11ea48f46… | ba0047e9e063… |
| 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 | 49288-0150-3 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 49288-0150-1 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 49288-0150-5 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 49288-0150-4 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 49288-0150-2 | 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 | 49288-0150-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 49288-0150-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 49288-0150-5 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 49288-0150-4 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 49288-0150-2 | 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 | 49288-0150-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 49288-0150-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 49288-0150-5 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 49288-0150-4 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 49288-0150-2 | 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 | 49288-0150-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 49288-0150-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 49288-0150-5 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 49288-0150-4 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 49288-0150-2 | ad56d346431e… | cc804d4bbf1e… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Related label |
|---|---|
| 49288-0150-1 | Allergenic Extract |
| 49288-0150-2 | Allergenic Extract |
| 49288-0150-3 | Allergenic Extract |
| 49288-0150-4 | Allergenic Extract |
| 49288-0150-5 | Allergenic Extract |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49288-0150-1 | American Cockroach | 2 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 2 | 2 | |
| 49288-0150-2 | American Cockroach | 5 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 5 | 2 | |
| 49288-0150-3 | American Cockroach | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 10 | 2 | |
| 49288-0150-4 | American Cockroach | 30 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 30 | 2 | |
| 49288-0150-5 | American Cockroach | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 50 | 2 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| PERIPLANETA AMERICANA | ACTIVE INGREDIENT | 2RQ1L9N089 | AMERICAN COCKROACH INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 2 | |
| PERIPLANETA AMERICANA | ACTIVE MOIETY | 2RQ1L9N089 | AMERICAN COCKROACH INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | AMERICAN COCKROACH INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 2 | |
| SODIUM BICARBONATE | INACTIVE INGREDIENT | 8MDF5V39QO | AMERICAN COCKROACH INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | AMERICAN COCKROACH INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | AMERICAN COCKROACH INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49288-0150 | AMERICAN COCKROACH INJECTION, SOLUTION [ANTIGEN LABORATORIES, INC.] | 2 | Legacy NDC, 5 package rows | 20091119_ef112633-e979-4933-b34b-e4d5756a90dc.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 966777 | American cockroach allergenic extract 100 MG/ML Injectable Solution | PSN | ef112633-e979-4933-b34b-e4d5756a90dc | 2 |
| 966709 | American cockroach allergenic extract 20 MG/mL Injectable Solution | PSN | ef112633-e979-4933-b34b-e4d5756a90dc | 2 |
| 905261 | American cockroach allergenic extract 50 MG/ML Injectable Solution | PSN | ef112633-e979-4933-b34b-e4d5756a90dc | 2 |
| 966777 | American cockroach allergenic extract 100 MG/ML Injectable Solution | SCD | ef112633-e979-4933-b34b-e4d5756a90dc | 2 |
| 966709 | American cockroach allergenic extract 20 MG/ML Injectable Solution | SCD | ef112633-e979-4933-b34b-e4d5756a90dc | 2 |
| 905261 | American cockroach allergenic extract 50 MG/ML Injectable Solution | SCD | ef112633-e979-4933-b34b-e4d5756a90dc | 2 |
| 905261 | American cockroach allergenic extract 0.05 GM/ML Injectable Solution | SY | ef112633-e979-4933-b34b-e4d5756a90dc | 2 |
| 905261 | Periplaneta americana allergenic extract 0.05 GM/ML Injectable Solution | SY | ef112633-e979-4933-b34b-e4d5756a90dc | 2 |
| 966777 | Periplaneta americana allergenic extract 0.1 GM/ML Injectable Solution | SY | ef112633-e979-4933-b34b-e4d5756a90dc | 2 |
| 966777 | Periplaneta americana allergenic extract 100 MG/ML Injectable Solution | SY | ef112633-e979-4933-b34b-e4d5756a90dc | 2 |
| 966709 | Periplaneta americana allergenic extract 20 MG/ML Injectable Solution | SY | ef112633-e979-4933-b34b-e4d5756a90dc | 2 |
| 905261 | Periplaneta americana allergenic extract 50 MG/ML Injectable Solution | SY | ef112633-e979-4933-b34b-e4d5756a90dc | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 49288-0150-1 | 49288015001 | 2 mL in 1 VIAL, MULTI-DOSE | 2 ml | Historical |
| 49288-0150-2 | 49288015002 | 5 mL in 1 VIAL, MULTI-DOSE | 5 ml | Historical |
| 49288-0150-3 | 49288015003 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | Historical |
| 49288-0150-4 | 49288015004 | 30 mL in 1 VIAL, MULTI-DOSE | 30 ml | Historical |
| 49288-0150-5 | 49288015005 | 50 mL in 1 VIAL, MULTI-DOSE | 50 ml | Historical |