Pomalidomide

Product NDC
31722-772
11-digit product format
317220772
Labeler code
31722
Product ID
31722-772_4c3e8f7f-ef41-3672-e063-6294a90ac5d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pomalidomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA210236
Marketing category
ANDA
Marketing start
2026-02-28
Substance
POMALIDOMIDE
Active strength
3 mg/1
Pharmacologic classes
Thalidomide Analog [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210236-001POMALIDOMIDEPOMALIDOMIDE1MGCAPSULE / ORALAB2024-09-26
A210236-002POMALIDOMIDEPOMALIDOMIDE2MGCAPSULE / ORALAB2024-09-26
A210236-003POMALIDOMIDEPOMALIDOMIDE3MGCAPSULE / ORALAB2024-09-26
A210236-004POMALIDOMIDEPOMALIDOMIDE4MGCAPSULE / ORALAB2024-09-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A210236-001AB
A210236-002AB
A210236-003AB
A210236-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A210236-001POMALIDOMIDE1MGCAPSULE / ORALAB2024-09-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210236-002POMALIDOMIDE2MGCAPSULE / ORALAB2024-09-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210236-003POMALIDOMIDE3MGCAPSULE / ORALAB2024-09-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210236-004POMALIDOMIDE4MGCAPSULE / ORALAB2024-09-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210236-001POMALIDOMIDE1MGCAPSULE / ORAL2024-09-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210236-002POMALIDOMIDE2MGCAPSULE / ORAL2024-09-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210236-003POMALIDOMIDE3MGCAPSULE / ORAL2024-09-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210236-004POMALIDOMIDE4MGCAPSULE / ORAL2024-09-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A210236-001POMALIDOMIDE1MGCAPSULE / ORAL2024-09-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210236-002POMALIDOMIDE2MGCAPSULE / ORAL2024-09-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210236-003POMALIDOMIDE3MGCAPSULE / ORAL2024-09-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210236-004POMALIDOMIDE4MGCAPSULE / ORAL2024-09-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210236-001POMALIDOMIDE1MGCAPSULE / ORALAB2024-09-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210236-002POMALIDOMIDE2MGCAPSULE / ORALAB2024-09-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210236-003POMALIDOMIDE3MGCAPSULE / ORALAB2024-09-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210236-004POMALIDOMIDE4MGCAPSULE / ORALAB2024-09-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210236-001POMALIDOMIDE1MGCAPSULE / ORALAB2024-09-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210236-002POMALIDOMIDE2MGCAPSULE / ORALAB2024-09-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210236-003POMALIDOMIDE3MGCAPSULE / ORALAB2024-09-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210236-004POMALIDOMIDE4MGCAPSULE / ORALAB2024-09-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210236-001POMALIDOMIDE1MGCAPSULE / ORALAB2024-09-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210236-002POMALIDOMIDE2MGCAPSULE / ORALAB2024-09-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210236-003POMALIDOMIDE3MGCAPSULE / ORALAB2024-09-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210236-004POMALIDOMIDE4MGCAPSULE / ORALAB2024-09-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210236-001POMALIDOMIDE1MGCAPSULE / ORALAB2024-09-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210236-002POMALIDOMIDE2MGCAPSULE / ORALAB2024-09-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210236-003POMALIDOMIDE3MGCAPSULE / ORALAB2024-09-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210236-004POMALIDOMIDE4MGCAPSULE / ORALAB2024-09-262680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210236-001POMALIDOMIDE1MGCAPSULE / ORALAB2024-09-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210236-002POMALIDOMIDE2MGCAPSULE / ORALAB2024-09-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210236-003POMALIDOMIDE3MGCAPSULE / ORALAB2024-09-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210236-004POMALIDOMIDE4MGCAPSULE / ORALAB2024-09-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210236-001POMALIDOMIDE1MGCAPSULE / ORALAB2024-09-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A210236-002POMALIDOMIDE2MGCAPSULE / ORALAB2024-09-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A210236-003POMALIDOMIDE3MGCAPSULE / ORALAB2024-09-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A210236-004POMALIDOMIDE4MGCAPSULE / ORALAB2024-09-26d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210236-001POMALIDOMIDE1MGCAPSULE / ORALAB2024-09-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210236-002POMALIDOMIDE2MGCAPSULE / ORALAB2024-09-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210236-003POMALIDOMIDE3MGCAPSULE / ORALAB2024-09-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210236-004POMALIDOMIDE4MGCAPSULE / ORALAB2024-09-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A210236-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210236-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210236-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210236-004AB1011fe1cb6892…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210236-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210236-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210236-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210236-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210236-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210236-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210236-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210236-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210236-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210236-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210236-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210236-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210236-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210236-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210236-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210236-004AB12680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210236-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210236-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210236-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210236-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210236-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210236-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210236-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210236-004AB1d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210236-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210236-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210236-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210236-004AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Pomalidomide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POMALIDOMIDE3 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D2UX06XLB5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1369718Internal RxNorm lookup
1369726Internal RxNorm lookup
1369730Internal RxNorm lookup
1369734Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
52676691-e171-467c-ae55-b5dcc14062a4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
191ddea2-3e27-5c8d-dccc-59ef9a0abcf7Product name220250401
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-772-01Pomalidomide100 in 1 BOTTLECAPSULE1002
31722-772-21Pomalidomide21 in 1 BOTTLECAPSULE212
31722-772-32Pomalidomide6 in 1 CARTONCAPSULE62
31722-772-32Pomalidomide10 in 1 BLISTER PACKCAPSULE102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-772-21EA - Each31722-772af245eaa-47e3-4f76-891f-fb3cac09fb8e12026-04-20

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PomalidomidePOMALIDOMIDECamber Pharmaceuticals, Inc.52676691-e171-467c-ae55-b5dcc14062a42026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210236
application number: ANDA210236
ndc (product): 31722-772

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1369718pomalidomide 1 MG Oral CapsulePSN52676691-e171-467c-ae55-b5dcc14062a42
1369726pomalidomide 2 MG Oral CapsulePSN52676691-e171-467c-ae55-b5dcc14062a42
1369730pomalidomide 3 MG Oral CapsulePSN52676691-e171-467c-ae55-b5dcc14062a42
1369734pomalidomide 4 MG Oral CapsulePSN52676691-e171-467c-ae55-b5dcc14062a42
1369718pomalidomide 1 MG Oral CapsuleSCD52676691-e171-467c-ae55-b5dcc14062a42
1369726pomalidomide 2 MG Oral CapsuleSCD52676691-e171-467c-ae55-b5dcc14062a42
1369730pomalidomide 3 MG Oral CapsuleSCD52676691-e171-467c-ae55-b5dcc14062a42
1369734pomalidomide 4 MG Oral CapsuleSCD52676691-e171-467c-ae55-b5dcc14062a42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-772-0131722077201100 CAPSULE in 1 BOTTLE (31722-772-01) 100 capsule2026-02-28NoNoCurrent
31722-772-213172207722121 CAPSULE in 1 BOTTLE (31722-772-21) 21 capsule2026-02-28NoNoCurrent
31722-772-32317220772326 BLISTER PACK in 1 CARTON (31722-772-32) / 10 CAPSULE in 1 BLISTER PACK6 blister pack2026-02-28NoNoCurrent