What is NDC 50633-110?

50633-110 is the product NDC for CroFab (ovine crotalidae venoms immune fab), Crotalus atrox immune fab antivenin (Ovine) 1 g/1 + 3 more ingredients injection, powder, lyophilized, for solution, listed with the FDA by BTG International Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

CroFab (Ovine crotalidae venoms immune fab).

What is the active ingredient?

Crotalus atrox immune fab antivenin (Ovine), Agkistrodon piscivorus immune fab antivenin (Ovine), Crotalus scutulatus immune fab antivenin (Ovine), Crotalus adamanteus immune fab antivenin (Ovine).

BTG International Inc., NDC labeler code 50633. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for CroFab?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

CroFab NDC 50633-110 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50633-110Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50633-0110Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
50633-110-12	5063301101250633011012	2 VIAL, GLASS in 1 CARTON (50633-110-12) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (50633-110-11)Marketed from Oct 2, 2000

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): CroFab
Generic name (nonproprietary): ovine crotalidae venoms immune fab
Active ingredients: Crotalus atrox immune fab antivenin (Ovine) — 1 g/1Agkistrodon piscivorus immune fab antivenin (Ovine) — 1 g/1Crotalus scutulatus immune fab antivenin (Ovine) — 1 g/1Crotalus adamanteus immune fab antivenin (Ovine) — 1 g/1
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: BTG International Inc.NDC labeler code 50633
Product type: Plasma derivative
Marketing category: BLA — Biologics License ApplicationApplication BLA 103788
Marketing start: Oct 2, 2000
Listing expires: Dec 31, 2027
Other FDA classes: Antivenins (Chemical/Ingredient)Antivenins (Chemical/Ingredient)Antivenins (Chemical/Ingredient)Antivenins (Chemical/Ingredient)Passively Acquired Immunity (Physiologic effect)Passively Acquired Immunity (Physiologic effect)Passively Acquired Immunity (Physiologic effect)Passively Acquired Immunity (Physiologic effect)Venom Neutralization (Mechanism)Venom Neutralization (Mechanism)Venom Neutralization (Mechanism)Venom Neutralization (Mechanism)
Identifiers: Product ID 50633-110_4f536edd-c976-31e5-e063-6294a90a2a08SPL ID 4f536edd-c976-31e5-e063-6294a90a2a08
Pharmacologic class: Antivenin

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N450633011012 followed by a unit qualifier and the quantity

Package 50633-0110-12. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

The FDA listing for this product does not reference a label (SPL) set.

About NDC 50633-110

What is NDC 50633-110?: 50633-110 is the product NDC for CroFab (ovine crotalidae venoms immune fab), Crotalus atrox immune fab antivenin (Ovine) 1 g/1 + 3 more ingredients injection, powder, lyophilized, for solution, listed with the FDA by BTG International Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: CroFab (Ovine crotalidae venoms immune fab).
What is the active ingredient?: Crotalus atrox immune fab antivenin (Ovine), Agkistrodon piscivorus immune fab antivenin (Ovine), Crotalus scutulatus immune fab antivenin (Ovine), Crotalus adamanteus immune fab antivenin (Ovine).
Who is the labeler?: BTG International Inc., NDC labeler code 50633. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for CroFab?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

CroFab (Ovine crotalidae venoms immune fab) NDC 50633-110